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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:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269906
First received: December 22, 2005
Last updated: April 23, 2010
Last verified: April 2010
History of Changes
  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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

Drug Information available for: Abciximab
U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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)

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

Estimated Enrollment: 1400
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
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:

ClinicalTrials.gov Identifier: NCT00269906     History of Changes
Other Study ID Numbers: CR006271
Study First Received: December 22, 2005
Last Updated: April 23, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013