Coronary Heart DiseasePhase 4NCT06088433
Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After DCB for Coronary Small Vessel Disease
A Phase 4 study testing Ticagrelor, Clopidogrel and Aspirin in people with Coronary Heart Disease, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Ticagrelor, Clopidogrel and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Ticagrelor, Clopidogrel, Aspirin
- Keywords
- CHD, DCB, SAPT, Ticagrelor
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta/Brilique
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)
ClopidogrelDrug
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)
AspirinDrug
Also called Acetylsalicylic Acid
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)
| Study group | Role | What they receive |
|---|---|---|
| SAPT | Experimental | Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID Receives: Drug: Ticagrelor |
| DAPT | Active comparator | Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD Receives: Drug: Clopidogrel; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Measured: 12 months after randomization
Secondary outcomes (4)
Major Adverse Cardiovascular Events (Key secondary endpoint)
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
Measured: 1 month after randomization
Platelet inhibition rate (thromboelastogram)
Measured: 12 months after randomization
Rate of patients taking medicine as prescribed
Measured: 12 months after randomization
Rate of patients discontinued medication due to bleeding
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Nov 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Haiyan, Fu Wai Hospital, Beijing, China
- Investigators
- Haiyan Qian, MD, PhD, Principal investigator, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088433
- Sponsor's protocol ID
- 2022-I2M-C&T-B-050
- Status last verified
- Oct 2023
- First submitted
- 7 Jun 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06088433
- Acronym / sponsor ID
- 2022-I2M-C&T-B-050
- Conditions
- Coronary Heart Disease
- Keywords
- CHD, DCB, SAPT, Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAPT | Experimental | Drug: TicagrelorTicagrelor SAPT 90mgBID for 1 month, followed by 60mgBID |
| DAPT | Active comparator | Drug: Clopidogrel, Drug: AspirinAspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: Brilinta/BriliqueComparison 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 | SAPT |
| ClopidogrelComparison 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 | DAPT |
| AspirinAlso: Acetylsalicylic AcidComparison 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 | DAPT |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 12 months after randomization
A composite of mortality, non-fatal myocardial infarction, non-fatal stroke or target vessel revascularization
4 secondary outcomes
Major Adverse Cardiovascular Events (Key secondary endpoint)
Time frame: 1 month after randomization
Platelet inhibition rate (thromboelastogram)
Time frame: 12 months after randomization
Rate of patients taking medicine as prescribed
Time frame: 12 months after randomization
Rate of patients discontinued medication due to bleeding
Time frame: 12 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Qian, MD, PhD principal investigator
Fuwai Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor, Clopidogrel and Aspirin in people with Coronary Heart Disease, run by Fu Wai Hospital, Beijing, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Qian, MD, PhD (+8613811386143, ahqhy712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.