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

Centocor Ortho Biotech

Status and phase: Completed; Phase 3

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Angina, Unstable

Treatments: Drug: Placebo; Drug: Abciximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269906

CR006271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,265 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,265 participants in 2 patient groups, including a placebo group

Abciximab (c7E3 Fab)

Experimental group

Description:

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.

Treatment:

Drug: Abciximab

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo