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

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.

Conditions

• Myocardial Infarction

Interventions

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

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• Centocor, Inc.

  lead INDUSTRY

Principal Investigators

• Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-08-31

Primary Completion

2008-01-31

Completion

2008-01-31

Countries

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

Study Locations