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

Sponsor

Fu Wai Hospital, Beijing, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06088433

Collaborator

(none)

292

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Drug: Ticagrelor Drug: Clopidogrel Drug: Aspirin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

292 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAPT Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID	Drug: Ticagrelor Comparison of 12 month of ticagrelor SAPT（90mgBID1 month, followed by 60mgBID) versus 12 months of dual anti-platelet therapy (Aspirin 100mgQD+clopidogrel 75mgQD 1 month, followed by clopidogrel 75mgQD) Other Names: Brilinta/Brilique
Active Comparator: DAPT Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD	Drug: Clopidogrel Comparison of 12 month of ticagrelor SAPT（90mgBID1 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（90mgBID1 month, followed by 60mgBID) versus 12 months of dual anti-platelet therapy (Aspirin 100mgQD+clopidogrel 75mgQD 1 month, followed by clopidogrel 75mgQD) Other Names: Acetylsalicylic Acid

Arm

Intervention/Treatment

Experimental: SAPT

Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID

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)

Other Names:

Brilinta/Brilique

Active Comparator: DAPT

Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD

Drug: Clopidogrel

Drug: Aspirin

Other Names:

Acetylsalicylic Acid

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CHD patients aged 18-80 with clear indications for PCI, regardless of gender;
Received DCB treatment with only one small coronary artery (diameter 2.0-2.75mm);
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);
Willing to participate in trials and complete follow-up;
Signed an informed consent form approved by the Ethics Committee;

Exclusion Criteria:

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.
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;
Anticoagulant drugs are required for atrial fibrillation/deep vein thrombosis (including pulmonary embolism)/mechanical valve implantation;
Cardiomyopathy (HCM/DCM/RCM);
Severe ventricular arrhythmias requires radiofrequency ablation or ICD implantation;
Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease);
Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients;
Blood system diseases with coagulation disorders such as thrombocytopenia, leukemia, and hemophilia;
Thrombotic diseases such as antiphospholipid antibody syndrome;
Cognitive impairment;
Not willing to participate in experiments or cooperate with follow-up;