Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)
1 other identifier
interventional
8,250
1 country
97
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 permuted completely randomization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Oct 2020
Longer than P75 for phase_4 coronary-artery-disease
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2020
CompletedStudy Start
First participant enrolled
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2025
CompletedDecember 1, 2025
November 1, 2025
4.9 years
October 27, 2020
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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, median follow-up duration is 34.3 months.
Secondary Outcomes (9)
Incidence of all-cause mortality.
Through study completion, median follow-up duration is 34.3 months.
Incidence of cardiovascular death.
Through study completion, median follow-up duration is 34.3 months.
Incidence of nonfatal myocardial infarction.
Through study completion, median follow-up duration is 34.3 months.
Incidence of nonfatal stroke.
Through study completion, median follow-up duration is 34.3 months.
Incidence of NACE (net adverse clinical events).
Through study completion, median follow-up duration is 34.3 months.
- +4 more secondary outcomes
Other Outcomes (2)
Incidence of clinically relevant bleeding events.
Through study completion, median follow-up duration is 34.3 months.
Incidence of major bleeding events.
Through study completion, median follow-up duration is 34.3 months.
Study Arms (2)
Aspirin monotherapy
PLACEBO COMPARATORPatients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.
Clopidogrel and aspirin dual-antiplatelet therapy
EXPERIMENTALPatients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
Interventions
Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
- Planned to use anticoagulants during the study period.
- Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harbin Medical Universitylead
- Chinese Society of Cardiologycollaborator
- Lepu Medical Technology (Beijing) Co., Ltd.collaborator
Study Sites (97)
Xinqiao Hospital, Army Medical University
Chongqing, Chongqing Municipality, 400037, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001, China
The Fifth Hospital of Xiamen
Xiamen, Fujian, 361101, China
Guangdong Provincial People's Hospital
Zhongshan, Guangdong, 510080, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003, China
Central South University Xiangya School of Medicine Affiliated Haikou Hospital
Haikou, Hainan, 570208, China
Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University)
Haikou, Hainan, 570311, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061014, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000, China
Pingquan County Hospital
Chengde, Hebei, 067500, China
Harrison International Peace Hospital
Hengshui, Hebei, 053000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 052306, China
The Third Hospital of Shijiazhuang
Shijiazhuang, Hebei, 052360, China
Tangshan Central Hospital
Tangshan, Hebei, 063099, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, 054000, China
The Fifth Affiliated Hospital of Qiqihar Medical College, Daqing Longnan Hospital.
Daqing, Heilongjiang, 163001, China
Daqing People's Hosipital
Daqing, Heilongjiang, 163316, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Hospital of Harbin
Harbin, Heilongjiang, 150010, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150030, China
The Second Hospital of Harbin
Harbin, Heilongjiang, 150056, China
Harbin 242 Hospital
Harbin, Heilongjiang, 150066, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Beidahuang Industry Group General Hospital
Harbin, Heilongjiang, 150088, China
Shuangcheng People's Hospital
Harbin, Heilongjiang, 150100, China
Hegang Hekuang Hospital
Hegang, Heilongjiang, 154100, China
People's Hospital of Hegang City
Hegang, Heilongjiang, 154100, China
The Baoquanling Hospital of Beidahuang Group
Hegang, Heilongjiang, 154211, China
Nenjiang People's Hospital
Heihe, Heilongjiang, 161400, China
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 150086, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, 154002, China
Jiansanjiang Hospital of Beidahuang Group
Jiamusi, Heilongjiang, 156300, China
Jixi Jikuang Hospital
Jixi, Heilongjiang, 158100, China
Jixi People's Hospital
Jixi, Heilongjiang, 158100, China
Mishan People's Hospital
Mishan, Heilongjiang, 158300, China
Mudanjiang City Second People's Hospital
Mudanjiang, Heilongjiang, 157000, China
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, 157011, China
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, 157011, China
Mudanjiang First People's Hospital
Mudanjiang, Heilongjiang, 157011, China
Mudanjiang Hospital of Beidahuang Group
Mudanjiang, Heilongjiang, 158322, China
Qiqihar Jianhua Hospital
Qiqihar, Heilongjiang, 161000, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, 161000, China
The First Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, 161006, China
Shuangyashan Mining Group Hospital
Shuangyashan, Heilongjiang, 155100, China
Shuangyashan People's Hospital
Shuangyashan, Heilongjiang, 155100, China
Baoqing County People's Hospital
Shuangyashan, Heilongjiang, 155600, China
The Hongxinglong Hospital of Beidahuang Group
Shuangyashan, Heilongjiang, 155811, China
The First Hospital of Suihua City
Suihua, Heilongjiang, 152053, China
People's Hospital of Daxing'anling Region
Xing'anling, Heilongjiang, 165000, China
Tieli Medical Service Community Central Hospital
Yichun, Heilongjiang, 152500, China
The First Hospital of Yichun City
Yichun, Heilongjiang, 153000, China
Yichun Forestry Central Hospital
Yichun, Heilongjiang, 153000, China
Kaifeng Central Hospital
Kaifeng, Henan, 475001, China
Nanyang First People's Hospital
Nanyang, Henan, 473004, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007, China
Puyang People's Hospital
Puyang, Henan, 457000, China
First People's Hospital of Shangqiu
Shangqiu, Henan, 476005, China
Central Hospital of Yongcheng
Shangqiu, Henan, 476610, China
Xinxiang Second People's Hospital
Xinxiang, Henan, 453099, China
The People's Hospital of Yongcheng
Yongcheng, Henan, 476600, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, 450016, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Dancheng County People's Hospital
Zhoukou, Henan, 477150, China
Yichang Central People's Hospital
Yichang, Hubei, 443000, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017, China
Hulunbuir People's Hospital
Hulunbuir, Inner Mongolia, 021008, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
Affiliated Pizhou Hospital of Xuzhou Medical University
Pizhou, Jiangsu, 221300, China
First People's Hospital of Fuzhou
Fuzhou, Jiangxi, 344000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Third Betune Hospital of Jilin University
Changchun, Jilin, 130033, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Jilin Central General Hospital
Jilin, Jilin, 132011, China
Jilin Hospital of Chinese and Western Medicine
Jilin, Jilin, 132012, China
Songyuan Central Hospital
Songyuan, Jilin, 138001, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Central Hospital of Dalian University of Technology (Dalian municipal central hospital )
Dalian, Liaoning, 116089, China
General Hospital of Ningxia Medical University - Cardiovascular and Cerebrovascular Hospital
Yinchuan, Ningxia, 750002, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Shandong Healthcare Group Feicheng Hospital
Feicheng, Shandong, 271608, China
The Fifth People's Hospital of Jinan
Jinan, Shandong, 250022, China
Shandong Second Provincial General Hospital
Jinan, Shandong, 250031, China
The Fourth People's Hospital of Jinan
Jinan, Shandong, 250031, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
The Second People's Hospital of Liaocheng
Liaocheng, Shandong, 252699, China
The Affiliated Taian City Centeral Hospital of Qingdao University
Tai’an, Shandong, 271099, China
Zhongshan Hospital Wusong Branch, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Dazhou Central Hospital
Dazhou, Sichuan, 635099, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Related Publications (1)
Tian J, Wang Z, Wang Y, Wang F, Wang Y, Zhao P, Hou X, Peng X, Tian M, Wang D, Yu B. Rationale and Design of Dual Antiplatelet Therapy in Patients with Coronary Multi-Vessel Disease (DAPT-MVD): A Multicenter, Randomized, Controlled Trial. Clin Cardiol. 2024 Dec;47(12):e70049. doi: 10.1002/clc.70049.
PMID: 39587825DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Yu, M.D.,FACC
The Second Affiliated Hospital of Harbin Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label trial, and the investigators and subjects will not be blinded. Under these conditions, the following methods will be employed to minimize bias: 1. Clinical Endpoint Committee (CEC) is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest; 2. The statisticians are independent and blind to the grouping information.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 27, 2020
First Posted
November 12, 2020
Study Start
October 28, 2020
Primary Completion
September 23, 2025
Study Completion
September 23, 2025
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share