Clinical trial NCT04624854: Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)
Official title: Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Myocardial Ischemia
Acute Coronary Syndrome
Heart Diseases
Syndrome Heart Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Coronary Disease
Vascular Diseases
Keywords: Coronary multivessel disease
Dual antiplatelet therapy
Percutaneous coronary intervention
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Chinese Society of Cardiology
name: Lepu Medical Technology (Beijing) Co., Ltd.
First posted: 2020-11-12
Enrollment: 8250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization. The treatment group will use aspirin + clopidogrel dual anti-platelet therapy for 12 months, and the control group will use aspirin monotherapy for 12 months.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke).
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Incidence of all-cause mortality.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of cardiovascular death.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of nonfatal myocardial infarction.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of nonfatal stroke.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of clinical adverse events.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of cardiovascular death or hospitalization.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of emergency revascularization.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of repeat revascularization.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of definite/possible stent thrombosis.
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
measure: Incidence of clinically relevant bleeding events.
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of major bleeding events.
timeFrame: Through study completion, an average of 2 years.
Locations:
city: Beijing
country: China
facility: Affiliated Beijing Luhe Hospital of Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiamen Fifth Hospital
state: Fujian
city: Qingyang
country: China
facility: Pingquan County Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: The Eighth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Hezuo
country: China
facility: Hezhou People's Hospital
state: Guangxi
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Haikou
country: China
facility: Haikou People's Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Shijiazhuang
state: Hebei
city: Tangshan
country: China
facility: Tangshan Central Hospital
state: Hebei
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Medical College
state: Hebei
city: Xingtai
country: China
facility: Xingtai Third Hospital
state: Hebei
city: Daqing
country: China
facility: Daqing Long Nan Hospital
state: Heilongjiang
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Daqing
country: China
facility: Daqing People's Hosipital
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Harbin First Hospital
state: Heilongjiang
city: Harbin
country: China
facility: Heilongjiang Province Hospital
state: Heilongjiang
city: Harbin
country: China
facility: Harbin Second Hospital
state: Heilongjiang
city: Harbin
country: China
facility: Harbin 242 Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Second Cancer Hospital of Heilongjiang Province
state: Heilongjiang
city: Harbin
country: China
facility: Shuangcheng People's Hospital
state: Heilongjiang
city: Hegang
country: China
facility: Hegang Mining Group General Hospital
state: Heilongjiang
city: Hegang
country: China
facility: Hegang People's Hospital
state: Heilongjiang
city: Hegang
country: China
facility: Heilongjiang Provincial Agricultural Reclamation Baoquanling Administration Center Hospital
state: Heilongjiang
city: Heihe
country: China
facility: Nenjiang People's Hospital
state: Heilongjiang
city: Jiamusi
country: China
facility: The Central Hospital of Jiamusi City
state: Heilongjiang
city: Jiamusi
country: China
facility: The First Affiliated Hospital of Jamusi University
state: Heilongjiang
city: Jiamusi
country: China
facility: The Jiansanjiang People's Hospital of Heilongjiang Land Reclamation
state: Heilongjiang
city: Jixi
country: China
facility: Jixi Jikuang Hospital
state: Heilongjiang
city: Jixi
country: China
facility: Jixi People's Hospital
state: Heilongjiang
city: Mishan
country: China
facility: Mishan People's Hospital
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang City Second People's Hospital
state: Heilongjiang
city: Mudanjiang
country: China
facility: Hongqi Hospital of Mudanjiang Medical University
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang Cardiovascular Hospital
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang First People's Hospital
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang Administration Center Hospital of Heilongjiang Land Reclamation
state: Heilongjiang
city: Qiqihar
country: China
facility: Qiqihar Jianhua Hospital
state: Heilongjiang
city: Qiqihar
country: China
facility: The Third Affiliated Hospital of Qiqihar Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: The First Affiliated Hospital of Qiqihar Medical University
state: Heilongjiang
city: Shuangyashan
country: China
facility: Emergency General Hospital of Shuangyashan
state: Heilongjiang
city: Shuangyashan
country: China
facility: Shuangyashan People's Hospital
state: Heilongjiang
city: Shuangyashan
country: China
facility: The People's Hospital of Baoqing
state: Heilongjiang
city: Shuangyashan
country: China
facility: Hongxinglong Central Hospital
state: Heilongjiang
city: Suihua
country: China
facility: Suihua First Hospital
state: Heilongjiang
city: Xing'anling
country: China
facility: Daxing'anling Prefecture People's Hospital
state: Heilongjiang
city: Yichun
country: China
facility: Tieli People's Hospital
state: Heilongjiang
city: Yichun
country: China
facility: Yichun First Hospital
state: Heilongjiang
city: Yichun
country: China
facility: Yichun Forestry Central Hospital
state: Heilongjiang
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Puyang
country: China
facility: Puyang People's Hospital
state: Henan
city: Shangqiu
country: China
facility: The First People's Hospital of Shangqiu
state: Henan
city: Shangqiu
country: China
facility: Central Hospital of Yongcheng
state: Henan
city: Xinxiang
country: China
facility: The Second People's Hospital of Xinxiang City
state: Henan
city: Yongcheng
country: China
facility: Yongcheng People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Seventh People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhoukou
country: China
facility: Dancheng People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Fourth Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Yichang
country: China
facility: Yichang First People's Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Pizhou
country: China
facility: Pizhou People's Hospital
state: Jiangsu
city: Fuzhou
country: China
facility: First People's Hospital of Fuzhou
state: Jiangxi
city: Chang chun
country: China
facility: The Third Affiliated Hospital of Jilin University
state: Jilin
city: Chang chun
country: China
facility: The Second Affiliated Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: Affiliated Hospital of Changchun Traditional Chinese Medicine University
state: Jilin
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Jilin
country: China
facility: Jilin Central Hospital
state: Jilin
city: Jilin
country: China
facility: Jilin Integrated Traditional Chinese and Western Medicine Hospital
state: Jilin
city: Jilin
country: China
facility: General Hospital of Jihua Group Company
state: Jilin
city: Songyuan
country: China
facility: Songyuan Central Hospital
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Cental Hospital
state: Liaoning
city: Hulunbeir
country: China
facility: Hulunbeir People's Hospital
state: Neimeng
city: Neimeng
country: China
facility: Inner Mongolia People's Hospital
state: Neimeng
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Fengcheng
country: China
facility: Feicheng Hospital of Shandong Guoxin Yiyang Group
state: Shandong
city: Jinan
country: China
facility: The Fifth People's Hospital of Jinan
state: Shandong
city: Jinan
country: China
facility: Shandong Second Provincial General Hospital
state: Shandong
city: Jinan
country: China
facility: The Fourth People's Hospital of Jinan
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Yanzhou District People's Hospital
state: Shandong
city: Liaocheng
country: China
facility: The Second People's Hospital of Liaocheng
state: Shandong
city: Tai'an
country: China
facility: Taian City Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Wusong hospital Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Xian
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Dazhou
country: China
facility: Dazhou Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Ürümqi
country: China
facility: Xinjiang Uiger Municipal People's Hospital
state: Xinjiang
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, M.D.,FACC
role: PRINCIPAL_INVESTIGATOR
References: