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A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction (Finesse)
This study has been completed.
Sponsors and Collaborators: Centocor, Inc.
PDL BioPharma, Inc.
Eli Lilly and Company
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00046228
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
Drug: Abciximab; reteplase; abciximab placebo; abciximab
Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
Phase III

MedlinePlus related topics: Heart Attack
Drug Information available for: Abciximab Reteplase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplase and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 non-intracranial and intracranial bleeding through discharge/day 7. [ Time Frame: 7 days or discharge, whichever is first ] [ Designated as safety issue: Yes ]

Enrollment: 2452
Study Start Date: August 2002
Study Completion Date: January 2008
Arms Assigned Interventions
001: Experimental Drug: Abciximab; reteplase; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
002: Experimental Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h
003: Experimental Drug: abciximab placebo; reteplase placebo, abciximab, abciximab
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 μg/kg/min, max 10 μg/min infusion x 12h

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 reteplase 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 reteplase or abciximab and placebo into a vein in their arm for up to 12 hours.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 catheterization within 4 hours of the qualifying Electrocardiogram
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046228

Sponsors and Collaborators
Centocor, Inc.
PDL BioPharma, Inc.
Eli Lilly and Company
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction - Finesse  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Centocor, Inc. ( Executive Director Clinical Research )
Study ID Numbers: CR005410, CR005410, FINESSE
Study First Received: September 24, 2002
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00046228  
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
abciximab
safety and efficacy
Myocardial infarction
reteplase
percutaneous coronary intervention

Study placed in the following topic categories:
Necrosis
Heart Diseases
Reteplase
Myocardial Ischemia
Vascular Diseases
Abciximab
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009