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

Centocor Ortho Biotech

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: abciximab placebo; reteplase placebo, abciximab, abciximab; Drug: abciximab; reteplase placebo; abciximab placebo; abciximab; Drug: Abciximab; reteplase; abciximab placebo; abciximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00046228

CR005410

FINESSE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,461 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,461 participants in 3 patient groups

001

Experimental group

Description:

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

Treatment:

Drug: abciximab placebo; reteplase placebo, abciximab, abciximab

Drug: Abciximab; reteplase; abciximab placebo; abciximab

Drug: Abciximab; reteplase; abciximab placebo; abciximab

Drug: abciximab placebo; reteplase placebo, abciximab, abciximab

002

Experimental group

Description:

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

Treatment:

Drug: abciximab; reteplase placebo; abciximab placebo; abciximab

Drug: Abciximab; reteplase; abciximab placebo; abciximab

Drug: Abciximab; reteplase; abciximab placebo; abciximab

Drug: abciximab; reteplase placebo; abciximab placebo; abciximab

003

Experimental group

Description:

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

Treatment:

Drug: abciximab placebo; reteplase placebo, abciximab, abciximab

Drug: abciximab; reteplase placebo; abciximab placebo; abciximab

Drug: abciximab; reteplase placebo; abciximab placebo; abciximab

Drug: abciximab placebo; reteplase placebo, abciximab, abciximab