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

Angina, Unstable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269906
• Other study ID #: CR006271
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: May 22, 2015
• Start date: May 1993
• Est. completion date: December 1995

Study information

• Verified date: May 2015
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1265
• Est. completion date: December 1995
• Est. primary completion date: December 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Angioplasty, Transluminal, Percutaneous Coronary

Intervention

Drug:
• Abciximab

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Died From Any Cause		Up to 30 Days	No
Primary	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	No
Secondary	Number of Participants With New Ischemia		From onset of infusion to percutaneous transluminal coronary angioplasty (PTCA), and from PTCA through 24 hours after PTCA	No
Secondary	Number of Participants With PTCA Complications		From onset of infusion to PTCA, and from PTCA through 24 hours after PTCA	No
Secondary	Number of Participants With use of Thrombolytic Agents in the Catheterization		Day 1	No
Secondary	Number of Participants With use of a Balloon Perfusion Catheter During Procedure		Day 1	No
Secondary	Number of Particpants With Late Major Clinical Events		From Day 30 up to 6 Months	No