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 Angioplasty, Transluminal, Percutaneous Coronary||Drug: Abciximab Drug: Placebo||Phase 3|
|Study Design:||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)|
- 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 ]
- 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 ]
|Study Start Date:||May 1993|
|Study Completion Date:||December 1995|
|Primary Completion Date:||December 1995 (Final data collection date for primary outcome measure)|
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.
Other Name: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269906
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|