Coronary Artery Disease Clinical Trial
Official title:
Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial
Verified date | June 2024 |
Source | Harbin Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective, multicenter, parallel, open-label, randomized, controlled, superiority trial. It is planned to recruit 8,250 patients with multi-vessel disease(MVD), and the patients will be followed-up for at least 12 months after being implanted with a drug-eluting stent (DES) at one of 100 different centers. All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization.
Status | Active, not recruiting |
Enrollment | 8250 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - The enrolled subjects must meet all of the following criteria: 1. Aged 18-75 years old (inclusive). 2. Patients with MVD who underwent DES implantation for 12 months. 3. Patients have been treated with aspirin and can tolerant of aspirin at doses of 75-150 mg/day as maintenance therapy during the study period. 4. Patients have signed informed consent. Exclusion Criteria: - Subjects who meet any one of the following criteria are excluded from the study: 1. Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol. 2. Contraindication to ADP receptor blockers or aspirin. 3. Planned to use anticoagulants during the study period. 4. Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period. 5. Planned major cardiac or non-cardiac surgery during the study period. 6. Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors. 7. Known severe liver disease(ALT/AST is 3 times above normal). 8. Subjects with renal failure who required or anticipated dialysis during the study period. 9. Platelet count <50×10^9/L. 10. Patients with: - A history of intracranial bleed or ischemic stroke at any time. - A central nervous system tumor or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time. - Intracranial or spinal cord surgery within 5 years. 11. Pregnancy or lactation or planned to pregnant during the study period. 12. Life expectancy < 1 year. 13. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer). 14. Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse). 15. Participation in another clinical study and did not reach the major endpoint. 16. Involvement in the planning and/or conduct of the study. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Beijing Luhe Hospital of Capital Medical University | Beijing | Beijing |
China | Cangzhou Central Hospital | Cangzhou | Hebei |
China | The Second Affiliated Hospital of Jilin University | Chang chun | Jilin |
China | The Third Affiliated Hospital of Jilin University | Chang chun | Jilin |
China | Affiliated Hospital of Changchun Traditional Chinese Medicine University | Changchun | Jilin |
China | The First Affiliated Hospital of Jilin University | Changchun | Jilin |
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
China | Affiliated Hospital of Chengde Medical University | Chengde | Hebei |
China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | The Second Affiliated Hospital of Army Medical University | Chongqing | Chongqing |
China | Dalian Municipal Cental Hospital | Dalian | Liaoning |
China | The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
China | Daqing Long Nan Hospital | Daqing | Heilongjiang |
China | Daqing Oilfield General Hospital | Daqing | Heilongjiang |
China | Daqing People's Hosipital | Daqing | Heilongjiang |
China | Dazhou Central Hospital | Dazhou | Sichuan |
China | Feicheng Hospital of Shandong Guoxin Yiyang Group | Fengcheng | Shandong |
China | First People's Hospital of Fuzhou | Fuzhou | Jiangxi |
China | Fujian Provincial Hospital | Fuzhou | Fujian |
China | The First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong |
China | Haikou People's Hospital | Haikou | Hainan |
China | Hainan General Hospital | Haikou | Hainan |
China | The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan |
China | Harbin 242 Hospital | Harbin | Heilongjiang |
China | Harbin First Hospital | Harbin | Heilongjiang |
China | Harbin Second Hospital | Harbin | Heilongjiang |
China | Heilongjiang Province Hospital | Harbin | Heilongjiang |
China | Shuangcheng People's Hospital | Harbin | Heilongjiang |
China | The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
China | The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
China | The Second Cancer Hospital of Heilongjiang Province | Harbin | Heilongjiang |
China | Hegang Mining Group General Hospital | Hegang | Heilongjiang |
China | Hegang People's Hospital | Hegang | Heilongjiang |
China | Heilongjiang Provincial Agricultural Reclamation Baoquanling Administration Center Hospital | Hegang | Heilongjiang |
China | Nenjiang People's Hospital | Heihe | Heilongjiang |
China | Harrison International Peace Hospital | Hengshui | Hebei |
China | The First Affiliated Hospital of University of South China | Hengyang | Hunan |
China | Hezhou People's Hospital | Hezuo | Guangxi |
China | Hulunbeir People's Hospital | Hulunbeir | Neimeng |
China | The Central Hospital of Jiamusi City | Jiamusi | Heilongjiang |
China | The First Affiliated Hospital of Jamusi University | Jiamusi | Heilongjiang |
China | The Jiansanjiang People's Hospital of Heilongjiang Land Reclamation | Jiamusi | Heilongjiang |
China | General Hospital of Jihua Group Company | Jilin | Jilin |
China | Jilin Central Hospital | Jilin | Jilin |
China | Jilin Integrated Traditional Chinese and Western Medicine Hospital | Jilin | Jilin |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Shandong Second Provincial General Hospital | Jinan | Shandong |
China | The Fifth People's Hospital of Jinan | Jinan | Shandong |
China | The Fourth People's Hospital of Jinan | Jinan | Shandong |
China | Yanzhou District People's Hospital | Jining | Shandong |
China | Jixi Jikuang Hospital | Jixi | Heilongjiang |
China | Jixi People's Hospital | Jixi | Heilongjiang |
China | Kaifeng Central Hospital | Kaifeng | Henan |
China | The First People's Hospital of Lianyungang | Lianyungang | Jiangsu |
China | The Second People's Hospital of Liaocheng | Liaocheng | Shandong |
China | Mishan People's Hospital | Mishan | Heilongjiang |
China | Hongqi Hospital of Mudanjiang Medical University | Mudanjiang | Heilongjiang |
China | Mudanjiang Administration Center Hospital of Heilongjiang Land Reclamation | Mudanjiang | Heilongjiang |
China | Mudanjiang Cardiovascular Hospital | Mudanjiang | Heilongjiang |
China | Mudanjiang City Second People's Hospital | Mudanjiang | Heilongjiang |
China | Mudanjiang First People's Hospital | Mudanjiang | Heilongjiang |
China | Zhongda Hospital Southeast University | Nanjing | Jiangsu |
China | Nanyang First People's Hospital | Nanyang | Henan |
China | The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan |
China | Inner Mongolia People's Hospital | Neimeng | Neimeng |
China | Pizhou People's Hospital | Pizhou | Jiangsu |
China | Puyang People's Hospital | Puyang | Henan |
China | Pingquan County Hospital | Qingyang | Gansu |
China | Qiqihar Jianhua Hospital | Qiqihar | Heilongjiang |
China | The First Affiliated Hospital of Qiqihar Medical University | Qiqihar | Heilongjiang |
China | The Third Affiliated Hospital of Qiqihar Medical University | Qiqihar | Heilongjiang |
China | Wusong hospital Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai |
China | Central Hospital of Yongcheng | Shangqiu | Henan |
China | The First People's Hospital of Shangqiu | Shangqiu | Henan |
China | Shenzhen People's Hospital | Shenzhen | Guangdong |
China | The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei |
China | The Third Hospital of Shijiazhuang | Shijiazhuang | Hebei |
China | Emergency General Hospital of Shuangyashan | Shuangyashan | Heilongjiang |
China | Hongxinglong Central Hospital | Shuangyashan | Heilongjiang |
China | Shuangyashan People's Hospital | Shuangyashan | Heilongjiang |
China | The People's Hospital of Baoqing | Shuangyashan | Heilongjiang |
China | Songyuan Central Hospital | Songyuan | Jilin |
China | Suihua First Hospital | Suihua | Heilongjiang |
China | Taian City Central Hospital | Tai'an | Shandong |
China | Tangshan Central Hospital | Tangshan | Hebei |
China | Tianjin Chest Hospital | Tianjin | Tianjin |
China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
China | The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
China | Xinjiang Uiger Municipal People's Hospital | Ürümqi | Xinjiang |
China | Renmin Hospital of Wuhan University | Wuhan | Hubei |
China | The Fourth Hospital of Wuhan | Wuhan | Hubei |
China | Zhongnan Hospital of Wuhan University | Wuhan | Hubei |
China | Xiamen Fifth Hospital | Xiamen | Fujian |
China | Shanxi Provincial People's Hospital | Xian | Shanxi |
China | Daxing'anling Prefecture People's Hospital | Xing'anling | Heilongjiang |
China | The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei |
China | Xingtai Third Hospital | Xingtai | Hebei |
China | The Second People's Hospital of Xinxiang City | Xinxiang | Henan |
China | Yichang First People's Hospital | Yichang | Hubei |
China | Tieli People's Hospital | Yichun | Heilongjiang |
China | Yichun First Hospital | Yichun | Heilongjiang |
China | Yichun Forestry Central Hospital | Yichun | Heilongjiang |
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
China | Yongcheng People's Hospital | Yongcheng | Henan |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
China | The Seventh People's Hospital of Zhengzhou | Zhengzhou | Henan |
China | Guangdong Provincial People's Hospital | Zhongshan | Guangdong |
China | The Eighth Affiliated Hospital, Sun Yat-Sen University | Zhongshan | Guangdong |
China | Dancheng People's Hospital | Zhoukou | Henan |
China | Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Harbin Medical University | Chinese Society of Cardiology, Lepu Medical Technology (Beijing) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of clinically relevant bleeding events. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of clinically relevant bleeding events (BARC, defined as type 2-5) in patients with MVD. | Through study completion, an average of 2 years. | |
Other | Incidence of major bleeding events. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of major bleeding events (BARC, defined as type3-5) in patients with MVD. | Through study completion, an average of 2 years. | |
Primary | Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke). | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD | Through study completion, an average of 2 years. | |
Secondary | Incidence of all-cause mortality. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of all-cause mortality in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of cardiovascular death. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of cardiovascular death in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of nonfatal myocardial infarction. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal myocardial infarction in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of nonfatal stroke. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal stroke in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of clinical adverse events. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of clinical adverse events (MACCE and BARC defined as type 2-5) in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of cardiovascular death or hospitalization. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of cardiovascular death or hospitalization (myocardial infarction, stroke, emergency revascularization, unstable angina or TIA) caused by thrombotic events in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of emergency revascularization. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of emergency revascularization in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of repeat revascularization. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of any repeat revascularization in patients with MVD. | Through study completion, an average of 2 years. | |
Secondary | Incidence of definite/possible stent thrombosis. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of definite/possible stent thrombosis in patients with MVD. | Through study completion, an average of 2 years. |
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