Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)
- Conditions
- ArteriosclerosisMyocardial IschemiaHeart DiseasesAcute Coronary SyndromeArterial Occlusive DiseasesCoronary Artery DiseaseSyndrome Heart DiseaseCardiovascular DiseasesCoronary DiseaseVascular Diseases
- Interventions
- Registration Number
- NCT04624854
- Lead Sponsor
- Harbin Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 8250
-
The enrolled subjects must meet all of the following criteria:
- Aged 18-75 years old (inclusive).
- Patients with MVD who underwent DES implantation for 12 months.
- 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.
- Patients have signed informed consent.
- Subjects who meet any one of the following criteria are excluded from the study:
-
Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol.
-
Contraindication to ADP receptor blockers or aspirin.
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Planned to use anticoagulants during the study period.
-
Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period.
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Planned major cardiac or non-cardiac surgery during the study period.
-
Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors.
-
Known severe liver disease(ALT/AST is 3 times above normal).
-
Subjects with renal failure who required or anticipated dialysis during the study period.
-
Platelet count <50×10^9/L.
-
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.
-
Pregnancy or lactation or planned to pregnant during the study period.
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Life expectancy < 1 year.
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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).
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Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).
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Participation in another clinical study and did not reach the major endpoint.
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Involvement in the planning and/or conduct of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin monotherapy Aspirin monotherapy Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization. Clopidogrel and Aspirin dual-antiplatelet therapy Clopidogrel and Aspirin dual-antiplatelet therapy Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
- Primary Outcome Measures
Name Time Method Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke). Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD
- Secondary Outcome Measures
Name Time Method Incidence of emergency revascularization. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of emergency revascularization in patients with MVD.
Incidence of repeat revascularization. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of any repeat revascularization in patients with MVD.
Incidence of all-cause mortality. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of all-cause mortality in patients with MVD.
Incidence of cardiovascular death. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of cardiovascular death in patients with MVD.
Incidence of nonfatal myocardial infarction. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal myocardial infarction in patients with MVD.
Incidence of cardiovascular death or hospitalization. Through study completion, an average of 2 years. 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.
Incidence of nonfatal stroke. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal stroke in patients with MVD.
Incidence of clinical adverse events. Through study completion, an average of 2 years. 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.
Incidence of definite/possible stent thrombosis. Through study completion, an average of 2 years. To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of definite/possible stent thrombosis in patients with MVD.
Trial Locations
- Locations (110)
Hezhou People's Hospital
🇨🇳Hezuo, Guangxi, China
The Second Affiliated Hospital of Army Medical University
🇨🇳Chongqing, Chongqing, China
Xiamen Fifth Hospital
🇨🇳Xiamen, Fujian, China
Pingquan County Hospital
🇨🇳Qingyang, Gansu, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Harbin Second Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Mishan People's Hospital
🇨🇳Mishan, Heilongjiang, China
Mudanjiang City Second People's Hospital
🇨🇳Mudanjiang, Heilongjiang, China
Hongqi Hospital of Mudanjiang Medical University
🇨🇳Mudanjiang, Heilongjiang, China
Mudanjiang Cardiovascular Hospital
🇨🇳Mudanjiang, Heilongjiang, China
Mudanjiang Administration Center Hospital of Heilongjiang Land Reclamation
🇨🇳Mudanjiang, Heilongjiang, China
Mudanjiang First People's Hospital
🇨🇳Mudanjiang, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical University
🇨🇳Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Qiqihar Medical University
🇨🇳Qiqihar, Heilongjiang, China
Shuangyashan People's Hospital
🇨🇳Shuangyashan, Heilongjiang, China
The People's Hospital of Baoqing
🇨🇳Shuangyashan, Heilongjiang, China
Suihua First Hospital
🇨🇳Suihua, Heilongjiang, China
Hongxinglong Central Hospital
🇨🇳Shuangyashan, Heilongjiang, China
Daxing'anling Prefecture People's Hospital
🇨🇳Xing'anling, Heilongjiang, China
Tieli People's Hospital
🇨🇳Yichun, Heilongjiang, China
Yichun First Hospital
🇨🇳Yichun, Heilongjiang, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
Puyang People's Hospital
🇨🇳Puyang, Henan, China
The First People's Hospital of Shangqiu
🇨🇳Shangqiu, Henan, China
Central Hospital of Yongcheng
🇨🇳Shangqiu, Henan, China
The Seventh People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
The Fourth Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Dancheng People's Hospital
🇨🇳Zhoukou, Henan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
First People's Hospital of Fuzhou
🇨🇳Fuzhou, Jiangxi, China
The Second 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
Jilin Integrated Traditional Chinese and Western Medicine Hospital
🇨🇳Jilin, Jilin, China
General Hospital of Jihua Group Company
🇨🇳Jilin, Jilin, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Hulunbeir People's Hospital
🇨🇳Hulunbeir, Neimeng, China
Feicheng Hospital of Shandong Guoxin Yiyang Group
🇨🇳Fengcheng, Shandong, China
The Fifth People's Hospital of Jinan
🇨🇳Jinan, Shandong, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shandong Second Provincial General Hospital
🇨🇳Jinan, Shandong, China
Yanzhou District People's Hospital
🇨🇳Jining, Shandong, China
Taian City Central Hospital
🇨🇳Tai'an, Shandong, China
Wusong hospital Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Xinjiang Uiger Municipal People's Hospital
🇨🇳Ürümqi, Xinjiang, China
The First Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Haikou People's Hospital
🇨🇳Haikou, Hainan, China
Affiliated Beijing Luhe Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Zhongshan, Guangdong, China
The Eighth Affiliated Hospital, Sun Yat-Sen University
🇨🇳Zhongshan, Guangdong, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Second Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
Harrison International Peace Hospital
🇨🇳Hengshui, Hebei, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Third Hospital of Shijiazhuang
🇨🇳Shijiazhuang, Hebei, China
Tangshan Central Hospital
🇨🇳Tangshan, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
🇨🇳Xingtai, Hebei, China
Xingtai Third Hospital
🇨🇳Xingtai, Hebei, China
Daqing Long Nan Hospital
🇨🇳Daqing, Heilongjiang, China
Daqing People's Hosipital
🇨🇳Daqing, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Harbin First Hospital
🇨🇳Harbin, Heilongjiang, China
Heilongjiang Province Hospital
🇨🇳Harbin, Heilongjiang, China
Harbin 242 Hospital
🇨🇳Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Cancer Hospital of Heilongjiang Province
🇨🇳Harbin, Heilongjiang, China
Shuangcheng People's Hospital
🇨🇳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
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
Jixi Jikuang Hospital
🇨🇳Jixi, Heilongjiang, China
Jixi People's Hospital
🇨🇳Jixi, Heilongjiang, China
Qiqihar Jianhua Hospital
🇨🇳Qiqihar, Heilongjiang, China
Emergency General Hospital of Shuangyashan
🇨🇳Shuangyashan, Heilongjiang, China
Yichun Forestry Central Hospital
🇨🇳Yichun, Heilongjiang, China
Kaifeng Central Hospital
🇨🇳Kaifeng, Henan, China
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
The Second People's Hospital of Xinxiang City
🇨🇳Xinxiang, Henan, China
Yongcheng People's Hospital
🇨🇳Yongcheng, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Yichang First People's Hospital
🇨🇳Yichang, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Pizhou People's Hospital
🇨🇳Pizhou, Jiangsu, China
The Third Affiliated Hospital of Jilin University
🇨🇳Chang chun, Jilin, China
Jilin Central Hospital
🇨🇳Jilin, Jilin, China
Songyuan Central Hospital
🇨🇳Songyuan, Jilin, China
Dalian Municipal Cental Hospital
🇨🇳Dalian, Liaoning, China
Inner Mongolia People's Hospital
🇨🇳Neimeng, Neimeng, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Shanxi Provincial People's Hospital
🇨🇳Xian, Shanxi, China
Dazhou Central Hospital
🇨🇳Dazhou, Sichuan, China
The Fourth People's Hospital of Jinan
🇨🇳Jinan, Shandong, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Second People's Hospital of Liaocheng
🇨🇳Liaocheng, Shandong, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China