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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03447379
• Other study ID #: 3-2017-0230
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2022
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1452
• Est. completion date: October 31, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• P2Y12 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)
• Aspirin plus P2Y12 antagonist
DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul	Souel

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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