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.
* Arm A : Single antiplatelet therapy (SAPT) group \- 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) followed by 11 months of single antiplatelet therapy (100mg aspirin q.d. or 75mg clopidogrel q.d.) * Arm B : Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel - 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) followed by 11 months of dual antiplatelet therapy (100mg aspirin q.d. and 75mg clopidogrel q.d.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,556
* Arm A : Single antiplatelet therapy (SAPT) with aspirin or clopidogrel \- 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.)→ Randomization → 11 months of single antiplatelet therapy (100mg aspirin q.d. or 75mg clopidogrel q.d.) * Arm B : Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel - 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) → Randomization → 11 months of dual antiplatelet therapy (100mg aspirin q.d. and 75mg clopidogrel q.d.)
Samsung Medical Center
Seoul, South Korea
RECRUITINGClinically significant bleeding
Bleeding Academic Research Consortium type 2, 3, or 5
Time frame: From 30 days after carotid artery stenting until 12 months
Combined cardiovascular and cerebrovascular accidents
Combined outcome of nonfatal stroke, nonfatal myocardial infarction, death due to cardio- and cerebrovascular diseases, and major bleeding events
Time frame: From 30 days after carotid artery stenting until 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.