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

NCT06088433 | Unknown Phase 4

• 1 other identifier: 2022-I2M-C&T-B-050
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

CHD; DCB; SAPT; Ticagrelor

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization

  12 months after randomization

Secondary Outcomes (4)

• Major Adverse Cardiovascular Events (Key secondary endpoint)

  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

Study Arms (2)

SAPT

EXPERIMENTAL

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

Drug: Ticagrelor

DAPT

ACTIVE COMPARATOR

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

Drug: Clopidogrel; Drug: Aspirin

Interventions

Ticagrelor 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)

Also known as: Brilinta/Brilique

SAPT

Clopidogrel 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 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)

Also known as: Acetylsalicylic Acid

DAPT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Ticagrelor; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Haiyan Qian, MD, PhD

  Fuwai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Qian, MD, PhD

CONTACT

+8613811386143; ahqhy712@163.com

Zhiyao Wei

CONTACT

+8615521192379; weizhiyaoyx@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: October 18, 2023
• Study Start: November 15, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

CN (1)