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

Phase 4

Active, not recruiting

• Conditions: Arteriosclerosis; Myocardial Ischemia; Heart Diseases; Acute Coronary Syndrome; Arterial Occlusive Diseases; Coronary Artery Disease; Syndrome Heart Disease; Cardiovascular Diseases; Coronary Disease; Vascular Diseases
• Interventions: Drug: Aspirin monotherapy; Drug: Clopidogrel and Aspirin dual-antiplatelet therapy

• 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

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8250

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.

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)

Affiliated Beijing Luhe Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

Xiamen Fifth Hospital; 🇨🇳 Xiamen, Fujian, China

Pingquan County Hospital; 🇨🇳 Qingyang, Gansu, China

The First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, 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

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