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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269906
First received: December 22, 2005
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Angina, Unstable
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Abciximab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Chimeric Anti-Platelet Therapy (Abciximab) in Unstable Angina Refractory to Standard Medical Therapy Trial (CAPTURE)

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Number of Participants who Died From Any Cause [ Time Frame: Up to 30 Days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With PTCA Complications [ Time Frame: From onset of infusion to PTCA, and from PTCA through 24 hours after PTCA ] [ Designated as safety issue: No ]
  • Number of Participants With use of Thrombolytic Agents in the Catheterization [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of Participants With use of a Balloon Perfusion Catheter During Procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of Particpants With Late Major Clinical Events [ Time Frame: From Day 30 up to 6 Months ] [ Designated as safety issue: No ]

Enrollment: 1265
Study Start Date: May 1993
Study Completion Date: December 1995
Primary Completion Date: December 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
Drug: Placebo

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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269906

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Publications:
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00269906     History of Changes
Other Study ID Numbers: CR006271
Study First Received: December 22, 2005
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Angina, unstable
Angioplasty, transluminal, percutaneous coronary
Abciximab

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015