Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269880
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2005-12-22
Brief Title:
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
Organization:
Centocor Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 abciximablow-dose weight-adjusted heparin abciximabstandard-dose weight-adjusted heparin or placebostandard-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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None