A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2038 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-11-30

Study Completion Date

1992-11-30

Brief Summary

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The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.

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Detailed Description

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This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplasty. The primary outcomes of the study include any of the following: the number of deaths from any cause, or myocardial infarctions and recurrent ischemic events requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).

Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.

Conditions

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Angina, Unstable Angioplasty, Transluminal, Percutaneous Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo soulution either bolus or infusion.

Abciximab and Placebo

Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours.

Group Type EXPERIMENTAL

Abciximab

Intervention Type DRUG

0.25 mg/kg of body weight of abciximab either bolus or infusion.

Placebo

Intervention Type DRUG

Matching Placebo soulution either bolus or infusion.

Abciximab

Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.

Group Type EXPERIMENTAL

Abciximab

Intervention Type DRUG

0.25 mg/kg of body weight of abciximab either bolus or infusion.

Interventions

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Abciximab

0.25 mg/kg of body weight of abciximab either bolus or infusion.

Intervention Type DRUG

Placebo

Matching Placebo soulution either bolus or infusion.

Intervention Type DRUG

Other Intervention Names

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c7E3 Fab

Eligibility Criteria

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Inclusion Criteria

* Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics

Exclusion Criteria

* Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment
* Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit
* Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis
* Treated with oral anticoagulants within 7 days (unless prothrombin time is =\< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No