CompletedPhase 4

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

China8,250 participantsStarted 2020-10-28

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion 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.

Exclusion criteria

✕. 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.

What they're measuring

Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke).

Timeframe: Through study completion, median follow-up duration is 34.3 months.

Trial details

NCT IDNCT04624854

SponsorHarbin Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-23

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