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

Phase 3

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: abciximab placebo; reteplase placebo, abciximab, abciximab; Drug: Abciximab; reteplase; abciximab placebo; abciximab; Drug: abciximab; reteplase placebo; abciximab placebo; abciximab

• Registration Number: NCT00046228
• Lead Sponsor: Centocor, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-09-24
• Study First Submitted QC: 2002-09-24
• Study First Posted: 2002-09-25
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-03-26
• Results First Submitted QC: 2009-03-27
• Results First Posted: 2009-05-15
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2461

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	abciximab placebo; reteplase placebo, abciximab, abciximab	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
001	Abciximab; reteplase; abciximab placebo; abciximab	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
002	abciximab; reteplase placebo; abciximab placebo; abciximab	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
002	Abciximab; reteplase; abciximab placebo; abciximab	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
003	abciximab; reteplase placebo; abciximab placebo; abciximab	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
003	abciximab placebo; reteplase placebo, abciximab, abciximab	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

Primary Outcome Measures

Name	Time	Method
The Composite of All-Cause Mortality or Complications of MI at 90 Days.	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).

Secondary Outcome Measures

Name	Time	Method
All-Cause Mortality Through 1 Year	1 year	All-cause mortality through 1 year from randomization.
All-Cause Mortality Through 90 Days	90 days	All cause mortality occurred through 90 days from randomization.
Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization	60 to 90 minutes
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days	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.