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

NCT00269906 | Completed Phase 3

• 1 other identifier: CR006271
• Study Type: interventional
• Target: 1,265
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Angina, unstable; Angioplasty, transluminal, percutaneous coronary; Abciximab

Outcome Measures

Primary Outcomes (2)

• Number of Participants who Died From Any Cause

  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)

  Up to 30 Days

Secondary Outcomes (5)

• Number of Participants With New Ischemia

  From onset of infusion to percutaneous transluminal coronary angioplasty (PTCA), and from PTCA through 24 hours after PTCA

• Number of Participants With PTCA Complications

  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

  Day 1

• Number of Participants With use of a Balloon Perfusion Catheter During Procedure

  Day 1

• Number of Particpants With Late Major Clinical Events

  From Day 30 up to 6 Months

Study Arms (2)

Abciximab (c7E3 Fab)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Abciximab DRUG

Also known as: c7E3 Fab

Abciximab (c7E3 Fab)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (1)

• 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.

  PMID: 9164316 RESULT

MeSH Terms

Conditions

Angina, Unstable

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: May 1, 1993
• Primary Completion: December 1, 1995
• Study Completion: December 1, 1995
• Last Updated: May 25, 2015

Record last verified: 2015-05