The present study is aimed to determine the safety and efficacy of Ticagrelor single antiplatelet therapy (SAPT) in patients with primary coronary small vessel disease at high risk of bleeding after drug coated balloon (DCB) therapy.
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 234 patients with high-risk bleeding and primary coronary small vessel disease after DCB enrolled in our research, randomly dividing into an experimental group (Ticagrelor SAPT, 90mg BID \* 1 month, followed by 60mg BID, n=117) and a control group (DAPT, aspirin 100mg QD+clopidogrel 75mg QD \* 1 month, followed by clopidogrel 75mg QD, n=117).The primary endpoint is 12 months of Major adverse cardiovascular events (MACE), including death, myocardial infarction, stroke, and target vessel revascularization. The key secondary endpoint is MACE at 1 month. The safety endpoint is BARC bleeding at all levels. Follow up will be conducted at 1 month and 12 months, and platelet inhibition rate will be measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
292
Comparison of 12 month of ticagrelor SAPT(90mgBID\*1 month, followed by 60mgBID) versus 12 months of dual anti-platelet therapy (Aspirin 100mgQD+clopidogrel 75mgQD \* 1 month, followed by clopidogrel 75mgQD)
Comparison of 12 month of ticagrelor SAPT(90mgBID\*1 month, followed by 60mgBID) versus 12 months of dual anti-platelet therapy (Aspirin 100mgQD+clopidogrel 75mgQD \* 1 month, followed by clopidogrel 75mgQD)
Comparison of 12 month of ticagrelor SAPT(90mgBID\*1 month, followed by 60mgBID) versus 12 months of dual anti-platelet therapy (Aspirin 100mgQD+clopidogrel 75mgQD \* 1 month, followed by clopidogrel 75mgQD)
Fuwai Hospital
Beijing, Beijing Municipality, China
Major Adverse Cardiovascular Events
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Time frame: 12 months after randomization
Major Adverse Cardiovascular Events (Key secondary endpoint)
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Time frame: 1 month after randomization
Platelet inhibition rate (thromboelastogram)
Time frame: 12 months after randomization
Rate of patients taking medicine as prescribed
Time frame: 12 months after randomization
Rate of patients discontinued medication due to bleeding
Time frame: 12 months after randomization
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