Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01701453
Status:
UNKNOWN
Last Update Posted:
2018-02-08
First Post:
2012-09-24
Brief Title:
Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes SMART-DATE
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Smart Angioplasty Research Team Safety of 6-month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes SMART-DATE
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
SMART-DATE
Brief Summary:
1 Objective To test the safety of 6 month-duration of dual antiplatelet therapy DAPT compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent DES implantation in patients with acute coronary syndrome ACS
2 Hypothesis A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events MACCE at 18-month after second-generation DES implantation in patients with ACS
2 Hypothesis A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events MACCE at 18-month after second-generation DES implantation in patients with ACS
Detailed Description:
1 Primary endpoint
- MACCE defined as a composite of all-cause mortality myocardial infarction and cerebrovascular events at 18 months after the index procedure
2 Secondary endpoint
Individual components of the primary endpoint at 18-month after the index procedure
Definiteprobable stent thrombosis defined by the Academic Research Consortium ARC at 18-month after the index procedure
Bleeding complication defined by Bleeding Academic Research Consortium BARC type 2 to 5 at 18-month after the index procedure
- MACCE defined as a composite of all-cause mortality myocardial infarction and cerebrovascular events at 18 months after the index procedure
2 Secondary endpoint
Individual components of the primary endpoint at 18-month after the index procedure
Definiteprobable stent thrombosis defined by the Academic Research Consortium ARC at 18-month after the index procedure
Bleeding complication defined by Bleeding Academic Research Consortium BARC type 2 to 5 at 18-month after the index procedure
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