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

December 22, 2005
May 22, 2015
February 1995
December 1995   (final data collection date for primary outcome measure)
  • 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 ]
Death, myocardial infarction, or repeat revascularization within 6 months; Death, myocardial infarction, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days
Complete list of historical versions of study NCT00269880 on ClinicalTrials.gov Archive Site
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 ]
Six-month angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses
Not Provided
Not Provided
 
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.
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
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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Angioplasty, Transluminal, Percutaneous Coronary
  • 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.
  • Drug: Abciximab
    Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Heparin
  • 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.
    Interventions:
    • Drug: Heparin
    • Drug: Abciximab
  • 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.
    Interventions:
    • Drug: Heparin
    • Drug: Abciximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2792
December 1995
December 1995   (final data collection date for primary outcome measure)

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%
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00269880
CR006262
Not Provided
Not Provided
Not Provided
Centocor, Inc.
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
May 2015

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