A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)
Information source: Centocor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction
Intervention: abciximab placebo; reteplase placebo, abciximab, abciximab (Drug); Abciximab; reteplase; abciximab placebo; abciximab (Drug); abciximab; reteplase placebo; abciximab placebo; abciximab (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Centocor, Inc. Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.
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.
Clinical Details
Official title: 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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The composite of all-cause mortality or complications of MI (rehospitalization or emergency department visit for Coronary Heart Failure, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization) at 90 days.
Secondary outcome: Complications of MI and all-cause mortality through 90 days; Percent of Subjects with ST-segment resolution > 70% from baseline at 60 to 90 minutes following randomization; Incidence of nonintracranial and intracranial bleeding through discharge/day 7.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who have prolonged, continuous (lasting at least 20 minutes) signs and
symptoms ofA 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
Locations and Contacts
Additional Information
Starting date: August 2002
Ending date: January 2008
Last updated: May 2, 2008
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