NCT06088433

Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After DCB for Coronary Small Vessel Disease

Safety and Efficacy of Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After Drug-coated Balloons for Coronary Small Vessel Disease: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation, Single-center Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Fu Wai Hospital, Beijing, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Ticagrelor	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)
DRUG	Clopidogrel	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)
DRUG	Aspirin	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)

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-11-30
• Completion: 2025-11-30
• First posted: 2023-10-18
• Last updated: 2023-10-18

Locations

1 site across 1 country: China