3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation (MODEL U-SES)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin; Drug: Thienopyridine

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 173-8606
    • Recruiting
    • Teikyo University Hospital
    • Contact: Ken Kozuma, MD, PhD; Phone Number: +81-3-3964-1211; Email: PXE00364@nifty.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: Aspirin; Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.	Drug: Aspirin; Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
Experimental: Thienopyridine; Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.	Drug: Thienopyridine; Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Major adverse cardiac event	3-month
Major adverse cardiac event	12-month
All cause death	3-month
All cause death	12-month
Cardiac death	3-month
Cardiac death	12-month
Myocardial infarction	3-month
Myocardial infarction	12-month
Stroke (ischemic and hemorrhagic)	3-month
Stroke (ischemic and hemorrhagic)	12-month
Target lesion revascularization	3-month
Target lesion revascularization	12-month
Target vessel revascularization	3-month
Target vessel revascularization	12-month
Readmission related to angina	3-month
Readmission related to angina	12-month
Stent thrombosis	3-month
Stent thrombosis (ARC definition)	12-month
Bleeding complications (BARC definition)	3-month
Bleeding complications (BARC definition)	12-month
Comparison of event rate by the type of antiplatelet agent	12-month

Collaborators and Investigators

• Sponsor: Teikyo University
• Investigators: Principal Investigator: Ken Kozuma, MD, PhD, Teikyo University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 31, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Drug-Eluting Stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: MODEL U-SES