Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271401
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2005-12-30
Brief Title:
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab an Anti-Platelet Therapy and Conventional Coronary Angioplasty With Abciximab
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Multicenter Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies Coronary Angioplasty Abciximab Intracoronary Stent Abciximab and Intracoronary Stent Placebo in Patients Undergoing Percutaneous Coronary Intervention
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 effectiveness and safety of intracoronary stenting with or without abciximab an anti-platelet therapy and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab an anti-platelet therapy and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention Patients will be randomly assigned to one of three treatment groups coronary angioplasty plus abciximab intracoronary stent plus abciximab or intracoronary stent plus placebo The primary measures of effectiveness will be a 30-day composite clinical outcome as determined by the number of deaths myocardial infarctions or urgent repeat revascularizations Please see attached results
Patients will receive one of three different treatments Coronary angioplasty plus abciximab Intracoronary stent plus abciximab or Intracoronary stent plus placebo
Patients will receive one of three different treatments Coronary angioplasty plus abciximab Intracoronary stent plus abciximab or Intracoronary stent plus placebo
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