A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab

Centocor Ortho Biotech

Status and phase: Completed; Phase 3

Conditions: Angioplasty, Transluminal, Percutaneous Coronary

Treatments: Drug: Placebo; Other: Angioplasty; Other: Intracoronary Stent; Drug: Heparin; Drug: Abxicimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00271401

CR006265

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.

Full description

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.

Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.

Enrollment: 2,399 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for elective or urgent percutaneous coronary intervention
• Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
• Having a target artery (native or graft) stenosis of >= 60% (visual estimation)

Exclusion criteria

• Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
• With a planned staged procedure or having an unprotected left main coronary artery stenosis > 50%
• With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
• Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
• Having hypertension with systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at the time of study entry, or a platelet count < 100,000/μL at baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,399 participants in 3 patient groups, including a placebo group

Angioplasty With Abciximab Plus Low-Dose Heparin

Experimental group

Description:

Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin.

Treatment:

Other: Angioplasty

Drug: Heparin

Drug: Abxicimab

Intracoronary Stent With Reo Pro Plus Low Dose Heparin

Experimental group

Description:

Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose).

Treatment:

Drug: Heparin

Other: Intracoronary Stent

Drug: Abxicimab

Intracoronary Stent With Placebo Plus Standard Dose Heparin

Placebo Comparator group

Description:

Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose).

Treatment:

Drug: Heparin

Drug: Placebo

Other: Intracoronary Stent