Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01103440
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2010-04-12
Brief Title:
Aspirin Resistance and Percutaneous Coronary Intervention PCI
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Randomized Pilot Single-center Study Investigator-Initiated Study to Look at an Aggressive Therapeutic Approach in Aspirin Resistant Patients Comparing to Standard for Patient Undergoing Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2018-01
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:
RESIST
Brief Summary:
The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin ASA resistant patients after percutaneous coronary intervention PCI
Detailed Description:
This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death MI stent thrombosis and urgent revascularization and bleeding up to 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None