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Sponsors and Collaborators: |
Centocor, Inc. PDL BioPharma, Inc. Eli Lilly and Company |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00046228 |
The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.
Condition | Intervention | Phase |
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Myocardial Infarction |
Drug: abciximab placebo; reteplase placebo, abciximab, abciximab Drug: Abciximab; reteplase; abciximab placebo; abciximab Drug: abciximab; reteplase placebo; abciximab placebo; abciximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplase and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction. |
Enrollment: | 2452 |
Study Start Date: | August 2002 |
Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Abciximab; reteplase; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
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002: Experimental |
Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
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003: Experimental |
Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
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The purpose of this medical research study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention. This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death, and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment. Patients will receive either abciximab and reteplase or abciximab alone. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive either abciximab and reteplase or abciximab and placebo into a vein in their arm for up to 12 hours.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Centocor, Inc. ( Executive Director Clinical Research ) |
Study ID Numbers: | CR005410, CR005410, FINESSE |
Study First Received: | September 24, 2002 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00046228 |
Health Authority: | United States: Food and Drug Administration |
abciximab safety and efficacy Myocardial infarction reteplase percutaneous coronary intervention |
Necrosis Heart Diseases Reteplase Myocardial Ischemia Vascular Diseases |
Abciximab Ischemia Infarction Myocardial Infarction |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |