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Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System

NCT04995159 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2150

Last updated 2021-08-06

No results posted yet for this study

Summary

This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.

Conditions

Interventions

DRUG

Single anti-platelet therapy

Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery.

DRUG

Dual anti-platelet therapy

Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Patients continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.

Sponsors & Collaborators

  • Lepu Medical Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yaling Han · The General Hospital of Northern Theater Command

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2026-01-31
Completion
2028-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995159 on ClinicalTrials.gov