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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

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.


Condition or disease Intervention/treatment
Coronary Artery Disease Drug: Aspirin Drug: Thienopyridine

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: 3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
Study Start Date : July 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Major adverse cardiac event [ Time Frame: 3-month ]
  3. Major adverse cardiac event [ Time Frame: 12-month ]
  4. All cause death [ Time Frame: 3-month ]
  5. All cause death [ Time Frame: 12-month ]
  6. Cardiac death [ Time Frame: 3-month ]
  7. Cardiac death [ Time Frame: 12-month ]
  8. Myocardial infarction [ Time Frame: 3-month ]
  9. Myocardial infarction [ Time Frame: 12-month ]
  10. Stroke (ischemic and hemorrhagic) [ Time Frame: 3-month ]
  11. Stroke (ischemic and hemorrhagic) [ Time Frame: 12-month ]
  12. Target lesion revascularization [ Time Frame: 3-month ]
  13. Target lesion revascularization [ Time Frame: 12-month ]
  14. Target vessel revascularization [ Time Frame: 3-month ]
  15. Target vessel revascularization [ Time Frame: 12-month ]
  16. Readmission related to angina [ Time Frame: 3-month ]
  17. Readmission related to angina [ Time Frame: 12-month ]
  18. Stent thrombosis [ Time Frame: 3-month ]
  19. Stent thrombosis (ARC definition) [ Time Frame: 12-month ]
  20. Bleeding complications (BARC definition) [ Time Frame: 3-month ]
  21. Bleeding complications (BARC definition) [ Time Frame: 12-month ]
  22. Comparison of event rate by the type of antiplatelet agent [ Time Frame: 12-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837003


Contacts
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Contact: Ken Kozuma, MD, PhD +81-3-3964-1211 PXE00364@nifty.com

Locations
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Japan
Teikyo University Hospital Recruiting
Tokyo, Japan, 173-8606
Contact: Ken Kozuma, MD, PhD    +81-3-3964-1211    PXE00364@nifty.com   
Sponsors and Collaborators
Teikyo University
Investigators
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Principal Investigator: Ken Kozuma, MD, PhD Teikyo University Hospital
Additional Information:

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Responsible Party: Teikyo University
ClinicalTrials.gov Identifier: NCT02837003    
Other Study ID Numbers: MODEL U-SES
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Keywords provided by Teikyo University:
Drug-Eluting Stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics