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 (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00271401
First received: December 30, 2005
Last updated: May 22, 2015
Last verified: May 2015
  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
Other: Angioplasty
Other: Intracoronary Stent
Drug: Abxicimab
Drug: Heparin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:
  • Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 2399
Study Start Date: July 1996
Study Completion Date: September 1997
Primary Completion Date: September 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Angioplasty With Abciximab Plus Low-Dose Heparin
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.
Other: Angioplasty Drug: Abxicimab Drug: Heparin
Experimental: Intracoronary Stent With Reo Pro Plus Low Dose Heparin
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).
Other: Intracoronary Stent Drug: Abxicimab Drug: Heparin
Placebo Comparator: Intracoronary Stent With Placebo Plus Standard Dose Heparin
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).
Other: Intracoronary Stent Drug: Heparin Drug: Placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00271401     History of Changes
Other Study ID Numbers: CR006265
Study First Received: December 30, 2005
Last Updated: May 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Stents
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:
Abciximab
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015