Clinical trial NCT06088433: Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After DCB for Coronary Small Vessel Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: CHD
DCB
SAPT
Ticagrelor
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Major Adverse Cardiovascular Events (Key secondary endpoint)
timeFrame: 1 month after randomization
measure: Platelet inhibition rate (thromboelastogram)
timeFrame: 12 months after randomization
measure: Rate of patients taking medicine as prescribed
timeFrame: 12 months after randomization
measure: Rate of patients discontinued medication due to bleeding
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Beijing, China
name: Haiyan Qian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: