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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: Ticagrelor; Drug: Clopidogrel; Drug: Aspirin

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 Type: Interventional
• Enrollment (Estimated): 292
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Haiyan Qian, MD, PhD; Phone Number: +8613811386143; Email: ahqhy712@163.com
• Study Contact Backup: Name: Zhiyao Wei; Phone Number: +8615521192379; Email: weizhiyaoyx@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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); 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); Other Names: Acetylsalicylic Acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (Key secondary endpoint)	A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization	1 month after randomization
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

Collaborators and Investigators

• Sponsor: Fu Wai Hospital, Beijing, China
• Investigators: Principal Investigator: Haiyan Qian, MD, PhD, Fuwai Hospital, Beijing, China

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ticagrelor; CHD; DCB; SAPT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor; Clopidogrel
• Other Study ID Numbers: 2022-I2M-C&T-B-050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No