NCT00046228

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,461 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	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; 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; 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 placebo; reteplase placebo, abciximab, abciximab	placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
DRUG	abciximab; reteplase placebo; abciximab placebo; abciximab	0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
DRUG	Abciximab; reteplase; abciximab placebo; abciximab	0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h

Timeline

• Start date: 2002-08-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2002-09-25
• Last updated: 2014-07-31
• Results posted: 2009-05-15

Locations

227 sites across 19 countries: United States, Argentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Israel, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom