Angioplasty, Transluminal, Percutaneous Coronary
Conditions
Keywords
Angioplasty, Transluminal, Percutaneous coronary
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.
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
Interventions
DRUGPlacebo
Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.
DRUGHeparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
DRUGAbciximab
Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
Sponsors
Centocor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses | up to 6 months |
Outcome results
None listed