3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation

Coronary Artery Disease Clinical Trial

— MODEL U-SES  

Official title:

3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02837003
• Other study ID #: MODEL U-SES
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2016
• Last updated: July 31, 2016
• Start date: July 2016
• Est. completion date: March 2019

Study information

• Verified date: July 2016
• Source: Teikyo University
• Contact: Ken Kozuma, MD, PhD
• Phone: +81-3-3964-1211
• Email: PXE00364[@]nifty.com
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).

Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.

• Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.

• Patients who have provided written informed consent.

Exclusion Criteria:

• Patients previously experienced stent thrombosis.

• Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.

• Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin
Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
• Thienopyridine
Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Locations

Country	Name	City	State
Japan	Teikyo University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Teikyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).		12-month	Yes
Secondary	Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).		3-month	Yes
Secondary	Major adverse cardiac event		3-month	Yes
Secondary	Major adverse cardiac event		12-month	Yes
Secondary	All cause death		3-month	Yes
Secondary	All cause death		12-month	Yes
Secondary	Cardiac death		3-month	Yes
Secondary	Cardiac death		12-month	Yes
Secondary	Myocardial infarction		3-month	Yes
Secondary	Myocardial infarction		12-month	Yes
Secondary	Stroke (ischemic and hemorrhagic)		3-month	Yes
Secondary	Stroke (ischemic and hemorrhagic)		12-month	Yes
Secondary	Target lesion revascularization		3-month	Yes
Secondary	Target lesion revascularization		12-month	Yes
Secondary	Target vessel revascularization		3-month	Yes
Secondary	Target vessel revascularization		12-month	Yes
Secondary	Readmission related to angina		3-month	Yes
Secondary	Readmission related to angina		12-month	Yes
Secondary	Stent thrombosis		3-month	Yes
Secondary	Stent thrombosis (ARC definition)		12-month	Yes
Secondary	Bleeding complications (BARC definition)		3-month	Yes
Secondary	Bleeding complications (BARC definition)		12-month	Yes
Secondary	Comparison of event rate by the type of antiplatelet agent		12-month	Yes