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

Primary Purpose

Coronary Heart Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Aspirin
Sponsored by
Fu Wai Hospital, Beijing, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring CHD, DCB, SAPT, Ticagrelor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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;

Sites / Locations

  • Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAPT

DAPT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular Events
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization

Secondary Outcome Measures

Major Adverse Cardiovascular Events (Key secondary endpoint)
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Platelet inhibition rate (thromboelastogram)
Rate of patients taking medicine as prescribed
Rate of patients discontinued medication due to bleeding

Full Information

First Posted
June 7, 2023
Last Updated
October 15, 2023
Sponsor
Fu Wai Hospital, Beijing, China
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1. Study Identification

Unique Protocol Identification Number
NCT06088433
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Wai Hospital, Beijing, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
CHD, DCB, SAPT, Ticagrelor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAPT
Arm Type
Experimental
Arm Description
Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID
Arm Title
DAPT
Arm Type
Active Comparator
Arm Description
Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilinta/Brilique
Intervention Description
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
Intervention Name(s)
Clopidogrel
Intervention Description
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
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic Acid
Intervention Description
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)
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events (Key secondary endpoint)
Description
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Time Frame
1 month after randomization
Title
Platelet inhibition rate (thromboelastogram)
Time Frame
12 months after randomization
Title
Rate of patients taking medicine as prescribed
Time Frame
12 months after randomization
Title
Rate of patients discontinued medication due to bleeding
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Qian, MD, PhD
Phone
+8613811386143
Email
ahqhy712@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyao Wei
Phone
+8615521192379
Email
weizhiyaoyx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyan Qian, MD, PhD
Organizational Affiliation
Fuwai Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

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

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