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CompletedNCT03447379Updated Mar 12, 2025

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

An interventional study of P2Y12 antagonist monotherapy and Aspirin plus P2Y12 antagonist in Coronary Artery Disease, sponsored by Gangnam Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,452
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study summary

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®)

02

Conditions studied

  • Coronary Artery Disease
03

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Age 86+
  2. Hemodynamically unstable patient
  3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
  4. Patients at high risk of bleeding, anemia, thrombocytopenia
  5. Patients requiring oral anticoagulants
  6. Pregnant women or women of childbearing age
  7. Life expectancy is less than one year
  8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
  9. Patients with a history of intracranial hemorrhage
  10. Patients with moderate to severe hepatic impairment
  11. Patients underwent coronary intervention with stenting within 1 year
  12. Patients with left-main lesions requiring coronary intervention
  13. Patients with chronic stricture lesions requiring treatment
  14. Patients with in-stent restenosis in a lesion requiring treatment
  15. Patients with bifurcation lesions requiring stenting in lateral branches
  16. Patients with lesions requiring more than 3 stents
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,452 participants (actual)

Study arms

  • Experimental
    P2Y12 antagonist monotherapy

    P2Y12 antagonist monotherapy after 3-month DAPT

    Drug: P2Y12 antagonist monotherapy

  • Active comparator
    Aspirin + P2Y12 antagonist

    Aspirin + P2Y12 antagonist after 3-month DAPT

    Drug: Aspirin plus P2Y12 antagonist

Interventions

  • DrugP2Y12 antagonist monotherapy

    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)

  • DrugAspirin plus P2Y12 antagonist

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

05

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular clinical events (MACCE)

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

    Time frame: between 3 and 12 month after the procedure

  2. Major bleeding

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

    Time frame: between 3 and 12 month after the procedure

06

Study locations

1 site
  • Gangnam Severance Hospital
    Seoul, Souel, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03447379
Lead sponsor
Gangnam Severance Hospital
Responsible party
Bumkee Hong (Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Feb 27, 2018
Start date
Dec 15, 2017
Primary completion
Mar 3, 2022
Completion
Aug 17, 2022
Last update
Mar 12, 2025

Study contacts

Bumkee Hong
principal investigator · Gangnam Severance Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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