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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624854
• Other study ID #: DAPT-MVD-201912
• Status: Recruiting
• Phase: Phase 4
• Start date: October 27, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Harbin Medical University
• Contact: Jinwei Tian, M.D.,FACC
• Phone: +86 18545851107
• Email: tianjinweidr2009[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: 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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arterial Occlusive Diseases
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Syndrome
• Syndrome Heart Disease
• Vascular Diseases

Intervention

Drug:
• Clopidogrel and Aspirin dual-antiplatelet therapy
Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
• Aspirin monotherapy
Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.

Locations

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	Xinqiao Hospital Army Medical University	Chongqing	Sichuan
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

Sponsors (3)

Lead Sponsor	Collaborator
Harbin Medical University	Chinese Society of Cardiology, Lepu Medical Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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.	12 months after randomization.
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.	12 months after randomization.
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	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.
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.	12 months after randomization.