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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAPT | Experimental | Ticagrelor SAPT 90mgBID for 1 month, followed by 60mgBID |
|
| DAPT | Active Comparator | Aspirin 100mgQD+Clopidogrel 75mgQD for 1 month, followed by clopidogrel 75mgQD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Qian, MD, PhD | Contact | +8613811386143 | ahqhy712@163.com | |
| Zhiyao Wei | Contact | +8615521192379 | weizhiyaoyx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyan Qian, MD, PhD | Fuwai Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| 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) |
|
| 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) |
|
|
| 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |