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OpenTrials
Completed

NCT Number: NCT03447379

Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, Souel, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19+
  • Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
  • Patients who understand the content of the subject description and voluntarily sign the subject

Exclusion criteria

  • Age 86+
  • Hemodynamically unstable patient
  • Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
  • Patients at high risk of bleeding, anemia, thrombocytopenia
  • Patients requiring oral anticoagulants
  • Pregnant women or women of childbearing age
  • Life expectancy is less than one year
  • Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
  • Patients with a history of intracranial hemorrhage
  • Patients with moderate to severe hepatic impairment
  • Patients underwent coronary intervention with stenting within 1 year
  • Patients with left-main lesions requiring coronary intervention
  • Patients with chronic stricture lesions requiring treatment
  • Patients with in-stent restenosis in a lesion requiring treatment
  • Patients with bifurcation lesions requiring stenting in lateral branches
  • Patients with lesions requiring more than 3 stents

Treatment and study plan

P2Y12 antagonist monotherapy

Drug

P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day)

Aspirin plus P2Y12 antagonist

Drug

DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year

Primary outcomes

  1. Major adverse cardiovascular clinical events (MACCE)

    Time frame: between 3 and 12 month after the procedure

    cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization

  2. Major bleeding

    Time frame: between 3 and 12 month after the procedure

    The Bleeding Academic Research Consortium (BARC) type 3 or 5

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2018
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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