Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Centocor, Inc.

Current Primary Outcome:

  • Number of Participants who Died From Any Cause [ Time Frame: 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) [ Time Frame: Up to 30 Days ]


Original Primary Outcome:

  • Any of the following within 30 days: Death from any cause
  • Myocardial infarction; or Recurrent ischemic events requiring urgent intervention (coronary artery bypass surgery, repeat coronary angioplasty, coronary stent placement, intra-aortic balloon pump)


Current Secondary Outcome:

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


Original Secondary Outcome: Components of the primary endpoint: Recurrent ischemia before or after the planned angioplasty; Myocardial infarction; Repeat angioplasty; Coronary artery bypass surgery; Deaths

Information By: Centocor, Inc.

Dates:
Date Received: December 22, 2005
Date Started: May 1993
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2015