A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk 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

NCT00269893

C0116T09 (Other Identifier)

CR006268

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.

Full description

This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplasty. The primary outcomes of the study include any of the following: the number of deaths from any cause, or myocardial infarctions and recurrent ischemic events requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).

Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.

Enrollment: 2,038 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics

Exclusion criteria

• Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment
• Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit
• Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis
• Treated with oral anticoagulants within 7 days (unless prothrombin time is =< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2,038 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.

Treatment:

Drug: Placebo

Abciximab and Placebo

Experimental group

Description:

Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours.

Treatment:

Drug: Abciximab

Drug: Placebo

Abciximab

Experimental group

Description:

Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.

Treatment:

Drug: Abciximab