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, Inc.2,399 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,399

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Interventions

AngioplastyOTHER

Intracoronary StentOTHER

AbxicimabDRUG

HeparinDRUG

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations

Time frame: Up to 30 days

Secondary Outcomes

Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status

Time frame: Up to 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.