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

Y

Yonsei University Health System (YUHS)

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Treatments

Drug: P2Y12 antagonist monotherapy
Drug: Aspirin plus P2Y12 antagonist

Study type

Interventional

Funder types

Other

Identifiers

NCT03447379
3-2017-0230

Details and patient eligibility

About

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®)

Enrollment

1,452 estimated patients

Sex

All

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

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

  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,452 participants in 2 patient groups

P2Y12 antagonist monotherapy
Experimental group
Description:
P2Y12 antagonist monotherapy after 3-month DAPT
Treatment:
Drug: P2Y12 antagonist monotherapy
Aspirin + P2Y12 antagonist
Active Comparator group
Description:
Aspirin + P2Y12 antagonist after 3-month DAPT
Treatment:
Drug: Aspirin plus P2Y12 antagonist

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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