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

NCT ID: NCT06088433

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2025-11-30

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SAPT

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

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

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)

DAPT

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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)

Aspirin

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

Brilinta/Brilique; Acetylsalicylic Acid

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role: lead

Responsible Party

Qian Haiyan

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiyan Qian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Beijing, China

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Haiyan Qian, MD, PhD

Role: CONTACT

ahqhy712@163.com

+8613811386143

Zhiyao Wei

Role: CONTACT

weizhiyaoyx@163.com

+8615521192379

Other Identifiers

2022-I2M-C&T-B-050

Identifier Type: -

Identifier Source: org_study_id