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

Purpose

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.

Condition	Intervention	Phase
Angioplasty, Transluminal, Percutaneous Coronary	Drug: Abciximab/angioplasty, abciximab/stent, placebo/stent	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

Drug Information available for: Abciximab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:

2400

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271401

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Publications:

Topol EJ, Mark DB, Lincoff AM, Cohen E, Burton J, Kleiman N, Talley D, Sapp S, Booth J, Cabot CF, Anderson KM, Califf RM. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1999 Dec 11;354(9195):2019-24. Erratum in: Lancet 2000 Mar 25;355(9209):1104.

[No authors listed] Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. The EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1998 Jul 11;352(9122):87-92.

ClinicalTrials.gov Identifier:	NCT00271401 History of Changes
Other Study ID Numbers:	CR006265
Study First Received:	December 30, 2005
Last Updated:	April 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Stents
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:

Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on May 23, 2013