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

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ClinicalTrials.gov Identifier: NCT02837003
Recruitment Status : Unknown
Verified July 2016 by Teikyo University.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Teikyo University

Tracking Information
First Submitted Date July 8, 2016
First Posted Date July 19, 2016
Last Update Posted Date August 2, 2016
Study Start Date July 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2016)
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). [ Time Frame: 12-month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 14, 2016)
  • 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). [ Time Frame: 3-month ]
  • Major adverse cardiac event [ Time Frame: 3-month ]
  • Major adverse cardiac event [ Time Frame: 12-month ]
  • All cause death [ Time Frame: 3-month ]
  • All cause death [ Time Frame: 12-month ]
  • Cardiac death [ Time Frame: 3-month ]
  • Cardiac death [ Time Frame: 12-month ]
  • Myocardial infarction [ Time Frame: 3-month ]
  • Myocardial infarction [ Time Frame: 12-month ]
  • Stroke (ischemic and hemorrhagic) [ Time Frame: 3-month ]
  • Stroke (ischemic and hemorrhagic) [ Time Frame: 12-month ]
  • Target lesion revascularization [ Time Frame: 3-month ]
  • Target lesion revascularization [ Time Frame: 12-month ]
  • Target vessel revascularization [ Time Frame: 3-month ]
  • Target vessel revascularization [ Time Frame: 12-month ]
  • Readmission related to angina [ Time Frame: 3-month ]
  • Readmission related to angina [ Time Frame: 12-month ]
  • Stent thrombosis [ Time Frame: 3-month ]
  • Stent thrombosis (ARC definition) [ Time Frame: 12-month ]
  • Bleeding complications (BARC definition) [ Time Frame: 3-month ]
  • Bleeding complications (BARC definition) [ Time Frame: 12-month ]
  • Comparison of event rate by the type of antiplatelet agent [ Time Frame: 12-month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
Official Title 3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
Brief 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Coronary Artery Disease
Intervention
  • Drug: Aspirin
    Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
  • Drug: Thienopyridine
    Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
Study Groups/Cohorts
  • Experimental: Aspirin
    Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.
    Intervention: Drug: Aspirin
  • Experimental: Thienopyridine
    Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.
    Intervention: Drug: Thienopyridine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 14, 2016)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02837003
Other Study ID Numbers MODEL U-SES
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Teikyo University
Study Sponsor Teikyo University
Collaborators Not Provided
Investigators
Principal Investigator: Ken Kozuma, MD, PhD Teikyo University Hospital
PRS Account Teikyo University
Verification Date July 2016