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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Aspirin plus P2Y12 antagonist; Drug: P2Y12 antagonist monotherapy

• Registration Number: NCT03447379
• Lead Sponsor: Gangnam Severance Hospital

Brief 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®)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-01
• Study Start: 2017-12-15
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-02-27
• Primary Completion: 2022-03-03
• Status Verified: 2022-08
• Study Completion: 2022-08-17
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1452

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin + P2Y12 antagonist	Aspirin plus P2Y12 antagonist	Aspirin + P2Y12 antagonist after 3-month DAPT
P2Y12 antagonist monotherapy	P2Y12 antagonist monotherapy	P2Y12 antagonist monotherapy after 3-month DAPT

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular clinical events (MACCE)	between 3 and 12 month after the procedure	cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization
Major bleeding	between 3 and 12 month after the procedure	The Bleeding Academic Research Consortium (BARC) type 3 or 5

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Souel, Korea, Republic of