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

Phase 4

Not yet recruiting

• Conditions: Coronary Heart Disease
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel; Drug: Aspirin

• Registration Number: NCT06088433
• Lead Sponsor: Fu Wai Hospital, Beijing, China

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-07
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-15
• Last Update Submitted: 2023-10-15
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Study Start: 2023-11-15
• Primary Completion: 2024-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

1. CHD patients aged 18-80 with clear indications for PCI, regardless of gender;
2. Received DCB treatment with only one small coronary artery (diameter 2.0-2.75mm);
3. High risk of bleeding (ARC high risk criteria for bleeding): Meets at least one main criterion (use of anticoagulants, liver dysfunction, tumors, history of gastrointestinal bleeding, history of peptic ulcers, creatinine clearance rate<30mL/min, hemoglobin<11g/L, platelet count<100 × 109/L) or 2 sub criteria (age ≥ 75 years old, creatinine clearance rate<60mL/min, history of stroke/TIA, hemoglobin 11-12.9g/L for males or 11-11.9g/L for females);
4. Willing to participate in trials and complete follow-up;
5. Signed an informed consent form approved by the Ethics Committee;

Exclusion Criteria

1. Simultaneously or plan to perform other coronary PCI procedures in batches, including stent implantation, DCB treatment for non-small vessel lesions, and DCB treatment for in stent restenosis lesions.
2. High ischemic risk: a. ACS within 1 year; b. Perform stent implantation or CABG surgery within 1 year; c. Double or multi vessel lesions rearched incomplete revascularization; d. In addition to the target lesions for DCB intervention, there are other stenosis ≥ 90%, regardless of whether PCI is planned or not;
3. Anticoagulant drugs are required for atrial fibrillation/deep vein thrombosis (including pulmonary embolism)/mechanical valve implantation;
4. Cardiomyopathy (HCM/DCM/RCM);
5. Severe ventricular arrhythmias requires radiofrequency ablation or ICD implantation;
6. Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease);
7. Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients;
8. Blood system diseases with coagulation disorders such as thrombocytopenia, leukemia, and hemophilia;
9. Thrombotic diseases such as antiphospholipid antibody syndrome;
10. Cognitive impairment;
11. Not willing to participate in experiments or cooperate with follow-up;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAPT	Ticagrelor	Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID
DAPT	Clopidogrel	Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD
DAPT	Aspirin	Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	12 months after randomization	A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events (Key secondary endpoint)	1 month after randomization	A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Platelet inhibition rate (thromboelastogram)	12 months after randomization
Rate of patients taking medicine as prescribed	12 months after randomization
Rate of patients discontinued medication due to bleeding	12 months after randomization

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China