Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-13
Brief Title:
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
Sponsor:
Woo-Keun Seo
Organization:
Samsung Medical Center
Study Overview
Official Title:
Clinical Trial to Obtain the Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk
Detailed Description:
Arm A Single antiplatelet therapy SAPT group
- 1 month of dual antiplatelet therapy100mg aspirin qd and 75mg clopidogrel qd followed by 11 months of single antiplatelet therapy 100mg aspirin qd or 75mg clopidogrel qd
Arm B Dual antiplatelet therapy DAPT with aspirin and clopidogrel - 1 month of dual antiplatelet therapy100mg aspirin qd and 75mg clopidogrel qd followed by 11 months of dual antiplatelet therapy 100mg aspirin qd and 75mg clopidogrel qd
- 1 month of dual antiplatelet therapy100mg aspirin qd and 75mg clopidogrel qd followed by 11 months of single antiplatelet therapy 100mg aspirin qd or 75mg clopidogrel qd
Arm B Dual antiplatelet therapy DAPT with aspirin and clopidogrel - 1 month of dual antiplatelet therapy100mg aspirin qd and 75mg clopidogrel qd followed by 11 months of dual antiplatelet therapy 100mg aspirin qd and 75mg clopidogrel qd
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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