Clinical trial NCT00269906: 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
Official title: Chimeric Anti-Platelet Therapy (Abciximab) in Unstable Angina Refractory to Standard Medical Therapy Trial (CAPTURE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina, Unstable
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Angina, unstable
Angioplasty, transluminal, percutaneous coronary
Abciximab
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-26
Enrollment: 1265
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants who Died From Any Cause
timeFrame: Up to 30 Days
measure: 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)
timeFrame: Up to 30 Days
Secondary outcomes:
measure: Number of Participants With New Ischemia
timeFrame: From onset of infusion to percutaneous transluminal coronary angioplasty (PTCA), and from PTCA through 24 hours after PTCA
measure: Number of Participants With PTCA Complications
timeFrame: From onset of infusion to PTCA, and from PTCA through 24 hours after PTCA
measure: Number of Participants With use of Thrombolytic Agents in the Catheterization
timeFrame: Day 1
measure: Number of Participants With use of a Balloon Perfusion Catheter During Procedure
timeFrame: Day 1
measure: Number of Particpants With Late Major Clinical Events
timeFrame: From Day 30 up to 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.