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.

Sponsor

Centocor, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00269880

Collaborator

(none)

2,792

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Angioplasty, Transluminal, Percutaneous Coronary	Drug: Placebo Drug: Heparin Drug: Abciximab	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

2792 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Feb 1, 1995

Actual Primary Completion Date :

Dec 1, 1995

Actual Study Completion Date :

Dec 1, 1995

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Death, myocardial infarction, or repeat revascularization within 6 months [up to 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 [Up to 30 Days]

Secondary Outcome Measures

Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses [up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director: Centocor, Inc. Clinical Trial, Centocor, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects with Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma

Publications

None provided.

Responsible Party:

Centocor, Inc.

ClinicalTrials.gov Identifier:

NCT00269880

Other Study ID Numbers:

CR006262

First Posted:

Dec 26, 2005

Last Update Posted:

May 25, 2015

Last Verified:

May 1, 2015

Keywords provided by Centocor, Inc.

Angioplasty, Transluminal, Percutaneous coronary

Additional relevant MeSH terms:

Heparin

Abciximab

Study Results

No Results Posted as of May 25, 2015