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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00271401
First received: December 30, 2005
Last updated: April 23, 2010
Last verified: April 2010
  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:


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