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

Tracking Information

First Received Date ^ICMJE

December 30, 2005

Last Updated Date

April 6, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Composite of deaths, myocardial infarctions, or urgent repeat revascularizations within 30 days of randomization

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00271401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Six-month clinical outcome; Six-month angiographic outcome as determined by quantitative coronary angiography in a subgroup of patients; Health economic analyses of medical costs, medical resource consumption, and cost effectiveness

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Randomized Trial Evaluating 30-Day and 6-Month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention

Brief Summary

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.

Detailed 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Angioplasty, Transluminal, Percutaneous Coronary

Intervention ^ICMJE

Drug: Abciximab/angioplasty, abciximab/stent, placebo/stent

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00271401

Responsible Party

Study ID Numbers ^ICMJE

CR006265

Study Sponsor ^ICMJE

Centocor, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP