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Medication Safety Issues
Sound-alike/look-alike issues:
Alteplase may be confused with Altace®
“tPA” abbreviation should not be used when writing orders for this medication; has been misread as TNKase (tenecteplase)
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (I.V.) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
Pronunciation
(AL te plase)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Management of acute myocardial infarction for the lysis of thrombi in coronary arteries; management of acute ischemic stroke
Acute myocardial infarction (AMI): Chest pain ?20 minutes, ?12-24 hours; S-T elevation ?0.1 mV in at least two ECG leads
Acute pulmonary embolism (APE): Age ?75 years: Documented massive pulmonary embolism by pulmonary angiography or echocardiography or high probability lung scan with clinical shock
Cathflo® Activase®: Restoration of central venous catheter function
Use: Unlabeled/Investigational
Acute peripheral arterial occlusive disease
Pregnancy Risk Factor
C
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to alteplase or any component of the formulation
Treatment of acute MI or PE: Active internal bleeding; history of CVA; recent intracranial or intraspinal surgery or trauma; intracranial neoplasm; arteriovenous malformation or aneurysm; known bleeding diathesis; severe uncontrolled hypertension
Treatment of acute ischemic stroke: Evidence of intracranial hemorrhage or suspicion of subarachnoid hemorrhage on pretreatment evaluation; recent (within 3 months) intracranial or intraspinal surgery; prolonged external cardiac massage; suspected aortic dissection; serious head trauma or previous stroke; history of intracranial hemorrhage; uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg diastolic); seizure at the onset of stroke; active internal bleeding; intracranial neoplasm; arteriovenous malformation or aneurysm; known bleeding diathesis including but not limited to: current use of anticoagulants or an INR >1.7, administration of heparin within 48 hours preceding the onset of stroke and an elevated aPTT at presentation, platelet count <100,000/mm3.
Other exclusion criteria (NINDS recombinant tPA study): Stroke or serious head injury within 3 months, major surgery or serious trauma within 2 weeks, GI or urinary tract hemorrhage within 3 weeks, aggressive treatment required to lower blood pressure, glucose level <50 mg/dL or >400 mg/dL, arterial puncture at a noncompressible site or lumbar puncture within 1 week, clinical presentation suggesting post-MI pericarditis, pregnancy, breast-feeding.
Warnings/Precautions
Concerns related to adverse effects:
• Arrhythmias: Coronary thrombolysis may result in reperfusion arrhythmias.
• Bleeding: Doses >150 mg are associated with increased risk of intracranial hemorrhage; monitor all potential bleeding sites. If serious bleeding occurs, the infusion of alteplase and heparin should be stopped.
Disease-related concerns:
• Conditions that increase bleeding risk: For the following conditions, the risk of bleeding is higher with use of thrombolytics and should be weighed against the benefits of therapy: Recent (within 10 days) major surgery (eg, CABG, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels), cerebrovascular disease, recent gastrointestinal or genitourinary bleeding, recent trauma, hypertension (systolic BP >175 mm Hg and/or diastolic BP >110 mm Hg), high likelihood of left heart thrombus (eg, mitral stenosis with atrial fibrillation), acute pericarditis, subacute bacterial endocarditis, hemostatic defects including ones caused by severe renal or hepatic dysfunction, significant hepatic dysfunction, diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions, septic thrombophlebitis or occluded AV cannula at seriously infected site and/or any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of location.
• Myocardial infarct (MI): Appropriate use: Follow standard management for MI while infusing alteplase.
• Stroke: Appropriate use: Treatment of patients with acute ischemic stroke more than 3 hours after symptom onset is not recommended. Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.
Concurrent drug therapy issues:
• Anticoagulants: Use with caution in patients receiving oral anticoagulants; increased risk of bleeding.
• Heparin: Concurrent heparin anticoagulation may contribute to bleeding.
Special populations:
• Elderly: Use with caution in patients with advanced age (eg, >75 years); increased risk of bleeding.
• Pregnancy: Use with caution in pregnancy; increased risk of bleeding.
Dosage form specific issues:
• Cathflo® Activase®: When used to restore catheter function, use Cathflo® cautiously in those patients with known or suspected catheter infections. Evaluate catheter for other causes of dysfunction before use. Avoid excessive pressure when instilling into catheter.
Other warnings/precautions:
• Administration: Intramuscular injections and nonessential handling of the patient should be avoided. Venipunctures should be performed carefully and only when necessary. If arterial puncture is necessary, use an upper extremity vessel that can be manually compressed.
Adverse Reactions
As with all drugs which may affect hemostasis, bleeding is the major adverse effect associated with alteplase. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the dosage administered, concurrent use of multiple agents which alter hemostasis, and patient predisposition. Rapid lysis of coronary artery thrombi by thrombolytic agents may be associated with reperfusion-related atrial and/or ventricular arrhythmia. Note: Lowest rate of bleeding complications expected with dose used to restore catheter function.
1% to 10%:
Cardiovascular: Hypotension
Central nervous system: Fever
Dermatologic: Bruising (1%)
Gastrointestinal: GI hemorrhage (5%), nausea, vomiting
Genitourinary: GU hemorrhage (4%)
Hematologic: Bleeding (0.5% major, 7% minor: GUSTO trial)
Local: Bleeding at catheter puncture site (15.3%, accelerated administration)
<1% (Limited to important or life-threatening): Intracranial hemorrhage (0.4% to 0.87% when dose is ?100 mg), retroperitoneal hemorrhage, pericardial hemorrhage, gingival hemorrhage, epistaxis, allergic reactions: anaphylaxis, anaphylactoid reactions, laryngeal edema, rash, and urticaria (<0.02%).
Additional cardiovascular events associated with use in MI: AV block, cardiogenic shock, heart failure, cardiac arrest, recurrent ischemia/infarction, myocardial rupture, electromechanical dissociation, pericardial effusion, pericarditis, mitral regurgitation, cardiac tamponade, thromboembolism, pulmonary edema, asystole, ventricular tachycardia, bradycardia, ruptured intracranial AV malformation, seizure, hemorrhagic bursitis, cholesterol crystal embolization
Additional events associated with use in pulmonary embolism: Pulmonary re-embolization, pulmonary edema, pleural effusion, thromboembolism
Additional events associated with use in stroke: Cerebral edema, cerebral herniation, seizure, new ischemic stroke
Drug Interactions
Aprotinin: May diminish the therapeutic effect of Thrombolytic Agents. Risk D: Consider therapy modification
Drotrecogin Alfa: Thrombolytic Agents may enhance the adverse/toxic effect of Drotrecogin Alfa. Bleeding may occur. Risk D: Consider therapy modification
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Thrombolytic Agents. Bleeding may occur. Risk D: Consider therapy modification
Nitroglycerin: May decrease the serum concentration of Alteplase. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Herb/Nutraceutical: Avoid cat's claw, dong quai, evening primrose, feverfew, red clover, horse chestnut, garlic, green tea, ginseng, ginkgo (all have additional antiplatelet activity).
Storage
Activase®: The lyophilized product may be stored at room temperature (not to exceed 30°C/86°F), or under refrigeration. Once reconstituted it should be used within 8 hours.
Cathflo® Activase®: Store lyophilized product in refrigerated. Once reconstituted, store at 2°C to 30°C (36°F to 86°F) and use within 8 hours.
Reconstitution
Activase®:
50 mg vial: Use accompanying diluent (50 mL sterile water for injection); do not shake. Final concentration: 1 mg/mL.
100 mg vial: Use transfer set with accompanying diluent (100 mL vial of sterile water for injection); no vacuum is present in 100 mg vial. Final concentration: 1 mg/mL.
Cathflo® Activase®: Add 2.2 mL SWFI to vial; do not shake. Final concentration: 1 mg/mL.
Compatibility
Stable in NS, sterile water for injection; incompatible with bacteriostatic water; variable stability (consult detailed reference) in D5W.
Y-site administration: Compatible: Lidocaine, metoprolol, propranolol. Incompatible: Dobutamine, dopamine, heparin, nitroglycerin.
Compatibility when admixed: Compatible: Lidocaine, morphine, nitroglycerin. Incompatible: Dobutamine, dopamine, heparin.
Mechanism of Action
Initiates local fibrinolysis by binding to fibrin in a thrombus (clot) and converts entrapped plasminogen to plasmin
Pharmacodynamics/Kinetics
Duration: >50% present in plasma cleared ~5 minutes after infusion terminated, ~80% cleared within 10 minutes
Excretion: Clearance: Rapidly from circulating plasma (550-650 mL/minute), primarily hepatic; >50% present in plasma is cleared within 5 minutes after the infusion is terminated, ~80% cleared within 10 minutes
Dosage
I.V.:
Coronary artery thrombi: Front loading dose (weight-based):
Patients >67 kg: Total dose: 100 mg over 1.5 hours; infuse 15 mg over 1-2 minutes. Infuse 50 mg over 30 minutes. Infuse remaining 35 mg of alteplase over the next hour. See “Note.”
Patients ?67 kg: Infuse 15 mg I.V. bolus over 1-2 minutes, then infuse 0.75 mg/kg (not to exceed 50 mg) over next 30 minutes, followed by 0.5 mg/kg over next 60 minutes (not to exceed 35 mg). See “Note.”
Note: Concurrently, begin heparin 60 units/kg bolus (maximum: 4000 units) followed by continuous infusion of 12 units/kg/hour (maximum: 1000 units/hour) and adjust to aPTT target of 1.5-2 times the upper limit of control.
Acute pulmonary embolism: 100 mg over 2 hours.
Acute ischemic stroke: Doses should be given within the first 3 hours of the onset of symptoms; recommended total dose: 0.9 mg/kg (maximum dose should not exceed 90 mg) infused over 60 minutes.
Load with 0.09 mg/kg (10% of the 0.9 mg/kg dose) as an I.V. bolus over 1 minute, followed by 0.81 mg/kg (90% of the 0.9 mg/kg dose) as a continuous infusion over 60 minutes. Heparin should not be started for 24 hours or more after starting alteplase for stroke.
Intracatheter: Central venous catheter clearance: Cathflo® Activase® 1 mg/mL:
Patients <30 kg: 110% of the internal lumen volume of the catheter, not to exceed 2 mg/2 mL; retain in catheter for 0.5-2 hours; may instill a second dose if catheter remains occluded
Patients ?30 kg: 2 mg (2 mL); retain in catheter for 0.5-2 hours; may instill a second dose if catheter remains occluded
Intra-arterial: Acute peripheral arterial occlusive disease (unlabeled use): 0.02-0.1 mg/kg/hour for up to 36 hours
Advisory Panel to the Society for Cardiovascular and Interventional Radiology on Thrombolytic Therapy recommendation: ?2 mg/hour and subtherapeutic heparin (aPTT <1.5 times baseline)
Administration: I.V.
Activase®: Acute MI: Accelerated infusion:
Bolus dose may be prepared by one of three methods:
1) Removal of 15 mL reconstituted (1 mg/mL) solution from vial
2) Removal of 15 mL from a port on the infusion line after priming
3) Programming an infusion pump to deliver a 15 mL bolus at the initiation of infusion
Remaining dose may be administered as follows:
50 mg vial: Either PVC bag or glass vial and infusion set
100 mg vial: Insert spike end of the infusion set through the same puncture site created by transfer device and infuse from vial
If further dilution is desired, may be diluted in equal volume of 0.9% sodium chloride or D5W to yield a final concentration of 0.5 mg/mL AD
Administration: Other
Cathflo® Activase®: Intracatheter: Instill dose into occluded catheter. Do not force solution into catheter. After a 30-minute dwell time, assess catheter function by attempting to aspirate blood. If catheter is functional, aspirate 4-5 mL of blood in patients ?10 kg or 3 mL in patients <10 kg to remove Cathflo® Activase® and residual clots. Gently irrigate the catheter with NS. If catheter remains nonfunctional, let Cathflo® Activase® dwell for another 90 minutes (total dwell time: 120 minutes) and reassess function. If catheter function is not restored, a second dose may be instilled.
Administration: I.V. Detail
Reconstituted solution should be clear or pale yellow and transparent. Avoid agitation during dilution.
pH: 5-7.3
Monitoring Parameters
When using for central venous catheter clearance: Assess catheter function by attempting to aspirate blood.
When using for management of acute myocardial infarction: Assess for evidence of cardiac reperfusion through resolution of chest pain, resolution of baseline ECG changes, preserved left ventricular function, cardiac enzyme washout phenomenon, and/or the appearance of reperfusion arrhythmias; assess for bleeding potential through clinical evidence of GI bleeding, hematuria, gingival bleeding, fibrinogen levels, fibrinogen degradation products, prothrombin times, and partial thromboplastin times.
Reference Range
Not routinely measured; literature supports therapeutic levels of 0.52-1.8 mcg/mL
Fibrinogen: 200-400 mg/dL
Activated partial thromboplastin time (aPTT): 22.5-38.7 seconds
Prothrombin time (PT): 10.9-12.2 seconds
Test Interactions
Altered results of coagulation and fibrinolytic agents
Patient Education
This medication can only be administered by infusion; you will be monitored closely during and after treatment. You will have a tendency to bleed easily; use caution to prevent injury (use electric razor, soft toothbrush, and use caution with knives, needles, or anything sharp). Follow instructions for strict bedrest to reduce the risk of injury. If bleeding occurs, report immediately and apply pressure to bleeding spot until bleeding stops completely. Report unusual pain (acute headache, joint pain, chest pain); unusual bruising or bleeding; blood in urine, stool, or vomit; bleeding gums; vision changes; or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Geriatric Considerations
No specific changes in use in elderly patients are necessary.
Anesthesia and Critical Care Concerns/Other Considerations
The Surgery Versus Thrombolysis for Ischemia of the Lower Extremity (STILE) trial (Ann Surg, 1994) compared surgery to intra-arterial thrombolytic therapy with either urokinase (250,000 units bolus, followed by 4000 units/minute for 4 hours, followed by 2000 units/minute for ?36 hours) or alteplase (0.05 mg/kg/hour for ?12 hours) in patients with acute (<14 days) or chronic peripheral arterial occlusive disease (PAOD). Patients with acute PAOD who received either fibrinolytic treatment had a shorter hospital stay and an improved amputation-free survival rate. There was no difference between alteplase or urokinase with regard to efficacy or bleeding events. A group from Stanford University recently did a retrospective comparison evaluating efficacy, safety, and cost of low-dose alteplase (<2 mg/hour) and subtherapeutic heparin to urokinase and therapeutic heparin for the treatment of PAOD or DVT (Sugimoto, 2003). Efficacy was similar for both groups. The average dose of alteplase was 0.86 mg/hour and the dose of urokinase was 2250 units/minute. Alteplase infusions were shorter and less expensive than urokinase.
Management of Intracerebral Hemorrhage (ICH) Due to Thrombolysis: Overall management of ICH is similar regardless of cause; however, iatrogenic spontaneous ICH may have specific treatments. According to the 2007 ACC/ASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage, fibrinolytic-related ICH should be treated with infusion of platelets (6-8 units) and cryoprecipitate which contains factor VIII (Class IIb recommendation).
Cardiovascular Considerations
ST-Elevation Myocardial Infarction: The 2004 ACC/AHA guidelines for the management of patients with acute myocardial infarction recommend prehospital thrombolysis in special circumstances (eg, transport time >30 minutes). Efforts to quickly identify and safely treat appropriate candidates for therapy continue. Reducing treatment delays is very important to improve mortality. Thrombolytic therapy is indicated in patients with ST-segment elevation >1 mm in two or more contiguous leads or at least two adjacent limb leads in patients with chest discomfort >30 minutes but ?12 hours. Patients with chest discomfort suggestive of ischemia and new-onset left bundle branch block (LBBB) are also candidates for thrombolysis. Generally, there is only a small trend for benefit of therapy after a delay of more than 12-24 hours, but thrombolysis may be considered for selected patients with ongoing ischemic pain and extensive ST elevation. Additional absolute contraindications for fibrinolysis use in ST-elevation myocardial infarction from the 2004 ACC/AHA guidelines: Any prior intracranial hemorrhage, ischemic stroke within 3 months (except one within 3 hours), significant closed head or facial trauma within 3 months. Additional relative contraindications include history of chronic severe, poorly-controlled hypertension, severe uncontrolled hypertension on presentation (systolic BP >180 mm Hg or diastolic >110 mm Hg; could be an absolute contraindication in low-risk patients), history of prior ischemic stroke >3 months, dementia, or known intracranial pathology, traumatic or prolonged (>10 minutes) CPR or major surgery (<3 weeks), recent (within 2-4 weeks) internal bleeding, noncompressible vascular punctures, pregnancy, active peptic ulcer, current use of anticoagulants.
Thrombolytic and GP IIb/IIIa Inhibitor: In the GUSTO V trial, patients with acute MI were randomized to standard-dose reteplase or half-dose reteplase (two boluses of 5 units each, 30 minutes apart) and full dose abciximab. Thirty-day mortality (primary endpoint) was similar in both groups. The combination treatment group had fewer deaths or nonfatal reinfarctions, less need for urgent revascularization, and fewer major ischemic complications. More bleeding occurred in the combination treatment group, but intracranial hemorrhage and nonfatal disabling stroke were similar in both groups. All cause mortality at one year was similar in both groups. In TIMI 14, the combination of full-dose abciximab (0.25 mg/kg bolus followed by a 12-hour infusion of 0.125 mcg/kg/minute, maximum 10 mcg/minute) and half-dose alteplase (15 mg bolus followed by 35 mg infusion over 60 minutes) resulted in 74% of patients achieving TIMI grade 3 flow at 90 minutes. The 2004 ACC/AHA guidelines for the management of patients with acute myocardial infarction suggests that abciximab and half-dose reteplase or tenecteplase may be considered for prevention of reinfarction in patients with an anterior MI, who are <75 years of age, and who have no risk factors for bleeding.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: As with all drugs which may affect hemostasis, bleeding is the major adverse effect associated with alteplase. Hemorrhage may occur at virtually any site; risk is dependent on multiple variables, including the dosage administered, concurrent use of multiple agents which alter hemostasis, and patient predisposition. Rapid lysis of coronary artery thrombi by thrombolytic agents may be associated with reperfusion-related atrial and/or ventricular arrhythmias.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess potential for interactions with other prescriptions, OTC medications, or herbal products patient may be taking (especially those medications that may affect coagulation or platelet function). Assess vital signs, results of laboratory tests, and ECG prior to, during, and after therapy. Arrhythmias may occur; antiarrhythmic drugs should be immediately available. Infusion site should be monitored and patient assessed for hemorrhage every 10 minutes (or according to institutional policy) during therapy and for 1 hour following therapy. Strict bedrest should be maintained and bleeding precautions should be instituted; avoid invasive procedures and activities that could cause trauma. Patient instructions determined by patient condition.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution, recombinant:
Activase®: 50 mg [29 million int. units; contains polysorbate 80; packaged with diluent]; 100 mg [58 million int. units; contains polysorbate 80; packaged with diluent and transfer device]
Cathflo® Activase®: 2 mg [contains polysorbate 80]
References
“A Comparison of Continuous Infusion of Alteplase With Double-Bolus Administration for Acute Myocardial Infarction. The Continuous Infusion Versus Double-Bolus Administration of Alteplase (COBALT) Investigators,” N Engl J Med, 1997, 337(16):1124-30.
“A Comparison of Reteplase With Alteplase for Acute Myocardial Infarction. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators,” N Engl J Med, 1997, 337(16):1118-23.
Albers GW, Bates VE, Clark WM, et al, “Intravenous Tissue-Type Plasminogen Activator for Treatment of Acute Stroke: The Standard Treatment With Alteplase to Reverse Stroke (STARS) Study,” JAMA, 2000, 283(9):1145-50.
Antman EM, Anbe SC, Alpert JS, et al, “ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction - Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction),” Circulation, 2004, 110(5):588-636. Available at: http://www.circulationaha.org/cgi/content/full/110/5/588. Last accessed October 26, 2004.
Antman EM, Giugliano RP, Gibson CM, et al, “Abciximab Facilitates the Rate and Extent of Thrombolysis: Results of the Thrombolysis in Myocardial Infarction (TIMI) 14 Trial. The TIMI 14 Investigators,” Circulation, 1999, 99(21):2720-32.
Broderick J, Connolly S, Feldmann E, et al, "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage in Adults: 2007 Update: A Guideline From the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group," Stroke, 2007, 38(6):2001-23. Available at http://stroke.ahajournals.org/cgi/content/short/STROKEAHA.107.183689.
Clark WM, Wissman S, Albers GW, et al, “Recombinant Tissue-Type Plasminogen Activator (Alteplase) for Ischemic Stroke 3 to 5 Hours After Symptom Onset: The ATLANTIS Study: A Randomized Controlled Trial,” JAMA, 1999, 282(21):2019-26.
Comerota AJ and Schmieder FA, “Intraoperative Lytic Therapy: Agents and Methods of Administration,” Semin Vasc Surg, 2001, 14(2):132-42.
Gerlach AT and Pickworth KK, “Use of Alteplase in Peripheral Arterial Occlusions: Outcomes and Complications,” Abstracts of the American College of Clinical Pharmacy Annual Meeting, Los Angeles, 2000, November 5-8; Abs No 47.
Kwiatkowski TG, Libman RB, Frankel M, et al, “Effects of Tissue Plasminogen Activator for Acute Ischemic Stroke at One Year. National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator Stroke Study Group,” N Engl J Med, 1999, 340(23):1781-7.
Leonard MC and Shermock KM, “Using Efficacy, Safety, and Cost Data to Support a Formulary Decision Regarding Thrombolytic Therapy,” Semin Vasc Surg, 2001, 14(2):150-5.
Lincoff AM, Califf RM, Van de Werf F, et al, “Mortality at 1 Year With Combination Platelet Glycoprotein IIb/IIIa Inhibition and Reduced-Dose Fibrinolytic Therapy vs Conventional Fibrinolytic Therapy for Acute Myocardial Infarction: GUSTO V Randomized Trial,” JAMA, 2002, 288(17):2130-5.
Lundergan CF, Reiner JS, McCarthy WF, et al, “Clinical Predictors of Early Infarct-Related Artery Patency Following Thrombolytic Therapy: Importance of Body Weight, Smoking History, Infarct-Related Artery and Choice of Thrombolytic Regimen: The GUSTO-I Experience. Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries,” J Am Coll Cardiol, 1998, 32(3):641-7.
“NINDS tPA Stroke Study Group. Generalized Efficacy for Acute Stroke: Subgroup Analysis of the NINDS tPA Stroke Study Group,” Stroke, 1997, 28(11):2119-25.
Ouriel K, “Current Status of Thrombolysis for Peripheral Arterial Occlusive Disease,” Ann Vasc Surg, 2002, 16(6):797-804.
Ponec D, Irwin D, Haire WD, et al, “Recombinant Tissue Plasminogen Activator (Alteplase) for Restoration of Flow in Occluded Central Venous Access Devices: A Double-Blind Placebo-Controlled Trial - The Cardiovascular Thrombolytic to Open Occluded Lines (COOL) Efficacy Trial,” J Vasc Interv Radiol, 2001, 12(8):951-5.
“Results of a Prospective, Randomised Trial Evaluating Surgery Versus Thrombolysis for Ischemia of the Lower Extremity. The STILE Trial,” Ann Surg, 1994, 220(3):251-66; discussion 266-8.
Semba CP, Murphy TP, Bakal CW, et al, “Thrombolytic Therapy With Use of Alteplase (rtPA) in Peripheral Arterial Occlusive Disease: Review of the Clinical Literature. The Advisory Panel,” J Vasc Interv Radiol, 2000, 11(2 Pt 1):149-61.
Sugimoto K, Hofmann LV, Razavi MK, et al, “The Safety, Efficacy, and Pharmacoeconomics of Low-Dose Alteplase Compared With Urokinase for Catheter-Directed Thrombolysis of Arterial and Venous Occlusions,” J Vasc Surg, 2003, 37(3):512-7.
The Gusto Angiographic Investigators, “The Effects of Tissue Plasminogen Activator, Streptokinase, or Both on Coronary-Artery Patency, Ventricular Function, and Survival After Acute Myocardial Infarction,” N Engl J Med, 1993, 329(22):1615-22.
“The NINDS tPA Stroke Study Group. Intracerebral Hemorrhage After Intravenous tPA Therapy for Ischemic Stroke,” Stroke, 1997, 28:2109-18.
“The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines,” Chest, 2004, 126(3 Suppl):163-703.
“Thrombolysis in the Management of Lower Limb Peripheral Arterial Occlusion - A Consensus Document. Working Party on Thrombolysis in the Management of Limb Ischemia,” Am J Cardiol, 1998, 81(2):207-18.
“Tissue Plasminogen Activator for Acute Ischemic Stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group,” N Engl J Med, 1995, 333(24):1581-7.
Topol EJ, “Reperfusion Therapy for Acute Myocardial Infarction With Fibrinolytic Therapy or Combination Reduced Fibrinolytic Therapy and Platelet Glycoprotein IIb/IIIa Inhibition: The GUSTO V Randomized Trial. GUSTO V Investigators,” Lancet, 2001, 357(9272):1905-14.
Valji K, “Evolving Strategies for Thrombolytic Therapy of Peripheral Vascular Occlusion,” J Vasc Interv Radiol, 2000, 11(4):411-20.
Zacharias JM, Weatherston CP, Spewak CR, et al, “Alteplase Versus Urokinase for Occluded Hemodialysis Catheters,” Ann Pharmacother, 2003, 37(1):27-33.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
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