A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Patients With Unstable Angina Not Responding to Standard Medical Therapy Who Are Eligible for Coronary Angioplasty

Sponsor

Centocor, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00269906

Collaborator

(none)

1,265

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, versus placebo in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty.

Condition or Disease	Intervention/Treatment	Phase
Angina, Unstable Angioplasty, Transluminal, Percutaneous Coronary	Drug: Abciximab Drug: Placebo	Phase 3

Detailed Description

This is a randomized, placebo-controlled study to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty. The primary outcomes of the study include any of the following within 30 days: the number of deaths from any cause, myocardial infarctions or the number of recurrent ischemic events requiring urgent intervention (such as a coronary artery bypass surgery, repeat coronary angioplasty, coronary stent placement, or intra-aortic balloon pump). Please see attached results.

Patients will be treated with abciximab or matching placebo.

Study Design

Study Type:

Interventional

Actual Enrollment :

1265 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Chimeric Anti-Platelet Therapy (Abciximab) in Unstable Angina Refractory to Standard Medical Therapy Trial (CAPTURE)

Study Start Date :

May 1, 1993

Actual Primary Completion Date :

Dec 1, 1995

Actual Study Completion Date :

Dec 1, 1995

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abciximab (c7E3 Fab) Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight abciximab as bolus intravenous injection followed by continuous infusion of abciximab at rate of 10 microgram per minute for at least 18 hours but not longer than 26 hours.	Drug: Abciximab Other Names: c7E3 Fab
Placebo Comparator: Placebo Participants will receive matching placebo as bolus IV injection followed by continuous infusion of matching placebo for at least 18 hours but no longer than 26 hours.	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Abciximab (c7E3 Fab)

Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight abciximab as bolus intravenous injection followed by continuous infusion of abciximab at rate of 10 microgram per minute for at least 18 hours but not longer than 26 hours.

Drug: Abciximab

Other Names:

c7E3 Fab

Placebo Comparator: Placebo

Participants will receive matching placebo as bolus IV injection followed by continuous infusion of matching placebo for at least 18 hours but no longer than 26 hours.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Number of Participants who Died From Any Cause [Up to 30 Days]
Number of Participant with any one of these: Myocardial Infraction, Recurrent Ischemic Events Requiring Urgent Intervention (Coronary Artery Bypass Surgery, Repeat Coronary Angioplasty, Coronary Stent Placement, Intra-aortic Balloon Pump) [Up to 30 Days]

Secondary Outcome Measures

Number of Participants With New Ischemia [From onset of infusion to percutaneous transluminal coronary angioplasty (PTCA), and from PTCA through 24 hours after PTCA]
Number of Participants With PTCA Complications [From onset of infusion to PTCA, and from PTCA through 24 hours after PTCA]
Number of Participants With use of Thrombolytic Agents in the Catheterization [Day 1]
Number of Participants With use of a Balloon Perfusion Catheter During Procedure [Day 1]
Number of Particpants With Late Major Clinical Events [From Day 30 up to 6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with refractory angina as evidenced by at least one episode of ischemia (chest pain and/or ST-T changes) despite bed rest and at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin, or persistent newly developed negative T-waves occurring or continuing after at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin
Having clinical signs and symptoms of angina at rest or minimal exertion with dynamic ST-segment and/or T-wave changes
Having an episode of chest pain within 48 hours prior to the start of study agent administration
Having a culprit lesion in a single native coronary vessel suitable for angioplasty on the qualifying angiogram

Exclusion Criteria:

Patients who have had a recent myocardial infarction, unless CK has returned to less than twice the upper limit of normal
Having features of ongoing ischemia that would require immediate intervention, or had a percutaneous transluminal coronary angioplasty (PTCA) within the past 24 hours
Having an unprotected occlusion of the main left coronary artery > 50%, a culprit lesion located in a venous or arterial bypass graft, or recent bleeding or a condition associated with increased bleeding risk
Receiving concurrent administration of oral anticoagulants at the time of study entry, administration of intravenous dextran (prior to or planned for use during angioplasty), or planned administration of thrombolytic agent prior to or during angioplasty
Having persistent hypertension at admission despite treatment, or a platelet count less than 100,000 per millimeter cubed