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

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)

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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