Status:
UNKNOWN
Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After DCB for Coronary Small Vessel Disease
Lead Sponsor:
Fu Wai Hospital, Beijing, China
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 d...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT06088433
Start Date
November 15 2023
End Date
November 30 2025
Last Update
October 18 2023
Active Locations (1)
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1
Fuwai Hospital
Beijing, Beijing Municipality, China