Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)

Last updated: June 17, 2024
Sponsor: Harbin Medical University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Coronary Artery Disease

Myocardial Ischemia

Vascular Diseases

Treatment

Aspirin monotherapy

Clopidogrel and Aspirin dual-antiplatelet therapy

Clinical Study ID

NCT04624854
DAPT-MVD-201912
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, andticlopidine), 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 duringthe 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 studyperiod.

  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.

  1. Pregnancy or lactation or planned to pregnant during the study period.

  2. Life expectancy < 1 year.

  3. Any condition which in the opinion of the investigator would make it unsafe orunsuitable for the patient to participate in this study (eg, active malignancy otherthan squamous cell or basal cell skin cancer).

  4. Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).

  5. Participation in another clinical study and did not reach the major endpoint.

  6. Involvement in the planning and/or conduct of the study.

Study Design

Total Participants: 8250
Treatment Group(s): 2
Primary Treatment: Aspirin monotherapy
Phase: 4
Study Start date:
October 27, 2020
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Affiliated Beijing Luhe Hospital of Capital Medical University

    Beijing, Beijing 101149
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • The Second Affiliated Hospital of Army Medical University

    Chongqing, Chongqing 516562
    China

    Site Not Available

  • Fujian Provincial Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Xiamen Fifth Hospital

    Xiamen, Fujian 361101
    China

    Site Not Available

  • Pingquan County Hospital

    Qingyang, Gansu 744517
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong 510700
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Zhongshan, Guangdong 510080
    China

    Site Not Available

  • The Eighth Affiliated Hospital, Sun Yat-Sen University

    Zhongshan, Guangdong 528406
    China

    Site Not Available

  • Hezhou People's Hospital

    Hezuo, Guangxi 542800
    China

    Site Not Available

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563003
    China

    Site Not Available

  • Haikou People's Hospital

    Haikou, Hainan 570208
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Site Not Available

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan 570311
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061014
    China

    Site Not Available

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei 067000
    China

    Site Not Available

  • Harrison International Peace Hospital

    Hengshui, Hebei 053000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 052306
    China

    Site Not Available

  • The Third Hospital of Shijiazhuang

    Shijiazhuang, Hebei 052360
    China

    Site Not Available

  • Tangshan Central Hospital

    Tangshan, Hebei 063099
    China

    Site Not Available

  • The Second Affiliated Hospital of Xingtai Medical College

    Xingtai, Hebei 054000
    China

    Site Not Available

  • Xingtai Third Hospital

    Xingtai, Hebei 054000
    China

    Site Not Available

  • Daqing Long Nan Hospital

    Daqing, Heilongjiang 163001
    China

    Site Not Available

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang 163316
    China

    Site Not Available

  • Daqing People's Hosipital

    Daqing, Heilongjiang 163316
    China

    Site Not Available

  • Daxing'anling Prefecture People's Hospital

    Daxing'anling, Heilongjiang 165000
    China

    Site Not Available

  • Harbin 242 Hospital

    Harbin, Heilongjiang 150066
    China

    Site Not Available

  • Harbin First Hospital

    Harbin, Heilongjiang 150010
    China

    Site Not Available

  • Harbin Second Hospital

    Harbin, Heilongjiang 150056
    China

    Site Not Available

  • Heilongjiang Province Hospital

    Harbin, Heilongjiang 150030
    China

    Site Not Available

  • Shuangcheng People's Hospital

    Harbin, Heilongjiang 150100
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150086
    China

    Site Not Available

  • The Second Cancer Hospital of Heilongjiang Province

    Harbin, Heilongjiang 150088
    China

    Site Not Available

  • Hegang Mining Group General Hospital

    Hegang, Heilongjiang 154100
    China

    Site Not Available

  • Hegang People's Hospital

    Hegang, Heilongjiang 154100
    China

    Site Not Available

  • Heilongjiang Provincial Agricultural Reclamation Baoquanling Administration Center Hospital

    Hegang, Heilongjiang 154211
    China

    Site Not Available

  • Nenjiang People's Hospital

    Heihe, Heilongjiang 161400
    China

    Site Not Available

  • The Central Hospital of Jiamusi City

    Jiamusi, Heilongjiang 150086
    China

    Site Not Available

  • The First Affiliated Hospital of Jamusi University

    Jiamusi, Heilongjiang 154002
    China

    Site Not Available

  • The Jiansanjiang People's Hospital of Heilongjiang Land Reclamation

    Jiamusi, Heilongjiang 156300
    China

    Site Not Available

  • Jixi Jikuang Hospital

    Jixi, Heilongjiang 158100
    China

    Site Not Available

  • Jixi People's Hospital

    Jixi, Heilongjiang 158100
    China

    Site Not Available

  • Mishan People's Hospital

    Mishan, Heilongjiang 158300
    China

    Site Not Available

  • Hongqi Hospital of Mudanjiang Medical University

    Mudanjiang, Heilongjiang 157011
    China

    Site Not Available

  • Mudanjiang Administration Center Hospital of Heilongjiang Land Reclamation

    Mudanjiang, Heilongjiang 158322
    China

    Site Not Available

  • Mudanjiang Cardiovascular Hospital

    Mudanjiang, Heilongjiang 157011
    China

    Site Not Available

  • Mudanjiang City Second People's Hospital

    Mudanjiang, Heilongjiang 157000
    China

    Site Not Available

  • Mudanjiang First People's Hospital

    Mudanjiang, Heilongjiang 157011
    China

    Site Not Available

  • Qiqihar Jianhua Hospital

    Qiqihar, Heilongjiang 161000
    China

    Site Not Available

  • The First Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang 161006
    China

    Site Not Available

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang 161000
    China

    Site Not Available

  • Emergency General Hospital of Shuangyashan

    Shuangyashan, Heilongjiang 155100
    China

    Site Not Available

  • Hongxinglong Central Hospital

    Shuangyashan, Heilongjiang 155811
    China

    Site Not Available

  • Shuangyashan People's Hospital

    Shuangyashan, Heilongjiang 155100
    China

    Site Not Available

  • The People's Hospital of Baoqing

    Shuangyashan, Heilongjiang 155600
    China

    Site Not Available

  • Suihua First Hospital

    Suihua, Heilongjiang 152053
    China

    Site Not Available

  • Daxing'anling Prefecture People's Hospital

    Xing'anling, Heilongjiang 165000
    China

    Site Not Available

  • Tieli People's Hospital

    Yichun, Heilongjiang 152500
    China

    Site Not Available

  • Yichun First Hospital

    Yichun, Heilongjiang 153000
    China

    Site Not Available

  • Yichun Forestry Central Hospital

    Yichun, Heilongjiang 153000
    China

    Site Not Available

  • Kaifeng Central Hospital

    Kaifeng, Henan 475001
    China

    Site Not Available

  • Nanyang First People's Hospital

    Nanyang, Henan 473004
    China

    Site Not Available

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan 473007
    China

    Site Not Available

  • Puyang People's Hospital

    Puyang, Henan 457000
    China

    Site Not Available

  • Central Hospital of Yongcheng

    Shangqiu, Henan 476610
    China

    Site Not Available

  • The First People's Hospital of Shangqiu

    Shangqiu, Henan 476005
    China

    Site Not Available

  • The Second People's Hospital of Xinxiang City

    Xinxiang, Henan 453099
    China

    Site Not Available

  • Yongcheng People's Hospital

    Yongcheng, Henan 476600
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • The Seventh People's Hospital of Zhengzhou

    Zhengzhou, Henan 450016
    China

    Site Not Available

  • Dancheng People's Hospital

    Zhoukou, Henan 477150
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Site Not Available

  • The Fourth Hospital of Wuhan

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430062
    China

    Site Not Available

  • Yichang First People's Hospital

    Yichang, Hubei 443000
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan 421001
    China

    Site Not Available

  • Inner Mongolia People's Hospital

    Inner Mongolia, Inner Mongolia 010017
    China

    Site Not Available

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu 222002
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Pizhou People's Hospital

    Pizhou, Jiangsu 221300
    China

    Site Not Available

  • First People's Hospital of Fuzhou

    Fuzhou, Jiangxi 344000
    China

    Site Not Available

  • The Second Affiliated Hospital of Jilin University

    Chang chun, Jilin 130041
    China

    Site Not Available

  • The Third Affiliated Hospital of Jilin University

    Chang chun, Jilin 130033
    China

    Site Not Available

  • Affiliated Hospital of Changchun Traditional Chinese Medicine University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Affiliated Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • General Hospital of Jihua Group Company

    Jilin, Jilin 132022
    China

    Site Not Available

  • Jilin Central Hospital

    Jilin, Jilin 132011
    China

    Site Not Available

  • Jilin Integrated Traditional Chinese and Western Medicine Hospital

    Jilin, Jilin 132012
    China

    Site Not Available

  • Songyuan Central Hospital

    Songyuan, Jilin 138001
    China

    Site Not Available

  • Dalian Municipal Cental Hospital

    Dalian, Liaoning 116089
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116011
    China

    Site Not Available

  • Hulunbeir People's Hospital

    Hulunbeir, Neimeng 021008
    China

    Site Not Available

  • Inner Mongolia People's Hospital

    Neimeng, Neimeng 010017
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750002
    China

    Site Not Available

  • Feicheng Hospital of Shandong Guoxin Yiyang Group

    Fengcheng, Shandong 271608
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250063
    China

    Site Not Available

  • Shandong Second Provincial General Hospital

    Jinan, Shandong 250031
    China

    Site Not Available

  • The Fifth People's Hospital of Jinan

    Jinan, Shandong 250022
    China

    Site Not Available

  • The Fourth People's Hospital of Jinan

    Jinan, Shandong 250031
    China

    Site Not Available

  • Yanzhou District People's Hospital

    Jining, Shandong 272100
    China

    Site Not Available

  • The Second People's Hospital of Liaocheng

    Liaocheng, Shandong 252699
    China

    Site Not Available

  • Taian City Central Hospital

    Tai'an, Shandong 271099
    China

    Site Not Available

  • Wusong hospital Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Xian, Shanxi 710068
    China

    Site Not Available

  • Xinqiao Hospital Army Medical University

    Chongqing, Sichuan 400000
    China

    Site Not Available

  • Dazhou Central Hospital

    Dazhou, Sichuan 635099
    China

    Site Not Available

  • Tianjin Chest Hospital

    Tianjin, Tianjin 300222
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830054
    China

    Site Not Available

  • Xinjiang Uiger Municipal People's Hospital

    Ürümqi, Xinjiang 830001
    China

    Site Not Available

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