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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06088433
Study type Interventional
Source Fu Wai Hospital, Beijing, China
Contact Haiyan Qian, MD, PhD
Phone +8613811386143
Email ahqhy712@163.com
Status Not yet recruiting
Phase Phase 4
Start date November 15, 2023
Completion date November 30, 2025

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