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Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation

NCT03008083 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2446

Last updated 2020-09-09

No results posted yet for this study

Summary

This study is a prospective,multi-center, open-label, randomized controlled clinical trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary intervention implanted sirolimus target- eluting stent with abluminal grooves containing a biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1 randomized to 3 months or 12 month of DAPT at index procedure.

Conditions

  • Drug-Eluting Stents
  • Percutaneous Coronary Intervention

Interventions

DRUG

3 months DAPT

Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 90 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.

DRUG

12 months DAPT

Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 360 days, 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

  • Junbo Ge, MD · Affiliated Zhongshan Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2020-12-31
Completion
2022-10-31

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 NCT03008083 on ClinicalTrials.gov