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

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

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.

Study Overview

• Status: Completed
• Conditions: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary
• Intervention / Treatment: Drug: Placebo; Drug: Abciximab

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 Type: Interventional
• Enrollment (Actual): 1265
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centocor, Inc.

Publications and helpful links

General Publications

• Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE Study. Lancet. 1997 May 17;349(9063):1429-35. Erratum In: Lancet 1997 Sep 6;350(9079):744.

Study record dates

Study Major Dates

• Study Start: May 1, 1993
• Primary Completion (Actual): December 1, 1995
• Study Completion (Actual): December 1, 1995

Study Registration Dates

• First Submitted: December 22, 2005
• First Submitted That Met QC Criteria: December 22, 2005
• First Posted (Estimate): December 26, 2005

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Angina, unstable; Abciximab; Angioplasty, transluminal, percutaneous coronary
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Unstable; Platelet Aggregation Inhibitors; Anticoagulants; Abciximab
• Other Study ID Numbers: CR006271