A Study Comparing the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Combination With Two Different Heparin Regimens in Patients Undergoing Percutaneous Coronary Intervention.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269880
First received: December 22, 2005
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

The purpose of this study is to compare the safety and effectiveness of abciximab, an anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary intervention when administered in combination with two different heparin regimens. Please see attached results.


Condition Intervention Phase
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Placebo
Drug: Heparin
Drug: Abciximab
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 Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Clinical Outcomes Following Percutaneous Coronary Intervention in Patients Treated With an Abciximab Bolus Plus 12-Hour Infusion Given With Either Standard-Dose Weight-Adjusted Heparin or Low-Dose Weight-Adjusted Heparin

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Death, myocardial infarction, or repeat revascularization within 6 months [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Death, myocardial infarction, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days [ Time Frame: Up to 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 2792
Study Start Date: February 1995
Study Completion Date: December 1995
Primary Completion Date: December 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo and Standard Dose of Heparin
Participants will receive bolus placebo followed by 12-hour infusion of placebo and bolus heparin at a dose of 100 units per kilogram of body weight.
Drug: Placebo
Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.
Drug: Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Active Comparator: Abciximab and Low Dose of Heparin
Participants will receive bolus abciximab at a dose of 0.25 milligram per kilogram (mg/kg) of body weight followed by 12-hour infusion of 0.125 microgram per kilogram per minute (mcg/kg/min) and bolus heparin at a dose of 70 units per kilogram of body weight.
Drug: Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Drug: Abciximab
Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
Active Comparator: Abciximab and Standard Dose Heparin
Participants will receive bolus abciximab at a dose of 0.25 mg/kg of body weight followed by 12-hour infusion of 0.125 mcg/kg/min and bolus heparin at a dose of 100 units per kilogram of body weight.
Drug: Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Drug: Abciximab
Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.

Detailed Description:

This is a randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of abciximab, an anti-platelet therapy, in combination with two different heparin regimens in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: abciximab/low-dose weight-adjusted heparin, abciximab/standard-dose weight-adjusted heparin, or placebo/standard-dose weight-adjusted heparin. The primary outcomes of the study include the number of deaths, myocardial infarctions, or repeat revascularizations within 6 months, and the number of deaths, myocardial infarctions, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days. Please see attached results.

Abciximab bolus plus 12-hour infusion with standard-dose weight-adjusted heparin; Abciximab bolus plus 12-hour infusion with low-dose weight-adjusted heparin; Placebo bolus plus 12-hour infusion with standard-dose weight-adjusted heparin

  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 with an FDA-approved device
  • Having a target artery (native or graft) stenosis of 60% by visual estimation

Exclusion Criteria:

  • Patients with unstable angina/non-Q-wave myocardial infarction meeting EPIC criteria within the previous 24 hours, or with acute Q-wave myocardial infarction meeting EPIC criteria with onset of chest pain within previous 24 hours
  • With active internal bleeding, having a condition that may increase the risk of bleeding, or currently receiving administration of oral anticoagulants at the time of study entry
  • With confirmed hypertension with systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
  • Having had a percutaneous coronary intervention within the previous 3 months
  • Having an unprotected left main coronary artery stenosis > 50%
  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: NCT00269880

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00269880     History of Changes
Other Study ID Numbers: CR006262
Study First Received: December 22, 2005
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
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 30, 2015