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.

NCT00046228 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Centocor, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	2461
Start date	2002-08
Completion	2008-01

Conditions

• Myocardial Infarction

Interventions

• abciximab placebo; reteplase placebo, abciximab, abciximab
• Abciximab; reteplase; abciximab placebo; abciximab
• abciximab; reteplase placebo; abciximab placebo; abciximab
• abciximab placebo; reteplase placebo, abciximab, abciximab
• abciximab; reteplase placebo; abciximab placebo; abciximab
• Abciximab; reteplase; abciximab placebo; abciximab

Primary outcomes

• 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).

Countries

United States, Argentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Israel, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom