This study is to compare the efficacy and safety of dabigatran ethidium b.i.d.+ clopidogrel + ASA \[100 mg q.d. \*1 month\] and warfarin + clopidogrel + ASA \[100 mg, q.d.\*1 month\] in Chinese NVAF patients undergoing PCI with stenting (elective or due to ACS).
This is an open-label, multi-center, randomized, controlled, prospective study.The object of this study is to compare the safety and efficacy of dabigatran etexilate combined with dual anti-platelet therapy versus warfarin combined with dual anti-platelet therapy in Chinese patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention. The subjects are randomized into study group and control group using central randomization for open-label dosing:(1) Study group: dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd. Aspirin is withdrawn 1 month later;(2) Control group: warfarin (according to clinical routine monitoring of INR, maintain the therapeutic rang at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd. Aspirin is withdrawn 1 month later;All patients should receive the study medication for 6 month. Primary endpoint:Time to the first occurrence of BARC-defined (grade 2-5) clinically relevant bleeding. Key secondary endpoint:Time to the first occurrence of net clinical adverse events. Net clinical adverse event is composed of major cardiovascular and cerebrovascular adverse events (all death, recurrent myocardial infarction, ischemia-induced revascularization of the target vessel, or stroke/systemic embolism) or BARC-defined (grade 2-5) clinically relevant bleeding. Secondary endpoints:1) Major cardiovascular and cerebrovascular adverse events 2) Major bleeding or clinically relevant non-major bleeding (ISTH definition) 3) Major bleeding (ISTH definition) 4) Any bleeding event (BARC-defined grade 1-5) 5) Clinically relevant bleeding (BARC-defined grade 2-5) 6) Bleeding (BARC-defined grade 3-5)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,120
dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by dabigatran 110mg bid + clopidogrel 75mg/d for at least 5 months
warfarin (according to clinical routine monitoring of INR, maintain the therapeutic range at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by warfarin + clopidogrel 75mg/d for at least 5 months
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
RECRUITINGclinically relevant bleeding
Time to the first occurrence of BARC-defined (grade 2-5) clinically relevant bleeding.
Time frame: 24 months
Time to the first occurrence of major cardiovascular and cerebrovascular adverse events
Time to the first occurrence of net clinical adverse events. Net clinical adverse event is composed of major cardiovascular and cerebrovascular adverse events (all death, recurrent myocardial infarction, ischemia-induced revascularization of the target vessel, or stroke/systemic embolism) or BARC-defined (grade 2-5) clinically relevant bleeding.
Time frame: 24 months
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