A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 reteplease 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 reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.

Official Title
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A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
* Drug: Abciximab; reteplase; abciximab placebo; abciximab
* Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
* Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
* Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
* Drug: Abciximab; reteplase; abciximab placebo; abciximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of A heart attack not eliminated with nitrates and onset within 6 hours of randomization,and confirmation by Electrocardiogram Exclusion Criteria: Low risk clinical presentation patients who will not be undergoing a catherization within 4 hours of the qualifying Electrocardiogram

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Abciximab; reteplase; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h | Drug: abciximab placebo; reteplase placebo, abciximab, abciximab<br>* placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h<br>Drug: Abciximab; reteplase; abciximab placebo; abciximab<br>* 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h<br>|
| Experimental: 002<br>abciximab; reteplase placebo; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h | Drug: Abciximab; reteplase; abciximab placebo; abciximab<br>* 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h<br>Drug: abciximab; reteplase placebo; abciximab placebo; abciximab<br>* 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h<br>|
| Experimental: 003<br>abciximab placebo; reteplase placebo, abciximab, abciximab placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h | Drug: abciximab; reteplase placebo; abciximab placebo; abciximab<br>* 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h<br>Drug: abciximab placebo; reteplase placebo, abciximab, abciximab<br>* placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite of All-Cause Mortality or Complications of MI at 90 Days. | Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization). | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of MI as Defined in the Primary Outcome Measure Through 90 Days | The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization. | 90 Days | 
| All-Cause Mortality Through 90 Days | All cause mortality occurred through 90 days from randomization. | 90 days | 
| Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization |  | 60 to 90 minutes | 
| All-Cause Mortality Through 1 Year | All-cause mortality through 1 year from randomization. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, percutaneous coronary intervention, abciximab, reteplase, safety and efficacy