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

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003610
• Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary

This randomized clinical trial found that among patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for NACE. Further research is required to analyze the impact of this strategy on individual outcomes, including bleeding events.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-08-17
• Results First Posted: 2024-03-07
• Last Update Posted: 24 June 2024

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A combination of cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, target lesion revascularization, major bleeding(BARC 3 or 5)

Secondary Outcome Measures

Name	Time	Method
cardiovascular-related death;myocardial infarction;stent thrombosis;stroke;target lesion revascularization;major bleeding(BARC 3 or 5)