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Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease

NCT03287167 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1720

Last updated 2020-09-09

No results posted yet for this study

Summary

This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal grooves containing a biodegradable polymer in High Bleeding Risk patients with coronary artery disease.

Conditions

  • Coronary Disease
  • Drug Eluting Stent
  • Percutaneous Coronary Intervention
  • Dual Antiplatelet Therapy

Interventions

DRUG

1 month DAPT

Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 1 month, after which patients will be given ASA and placebo in next 5 months and then continue on monotherapy with ASA only, unless contraindications for ASA emerge.

DRUG

6 months DAPT

Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 6 months, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yaling Han, MD · The General Hospital of Shenyang Military

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-07-31
Completion
2023-07-30

Countries

  • China

Study Locations

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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 NCT03287167 on ClinicalTrials.gov