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

NCT ID: NCT02837003

Last Updated: 2016-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental: Aspirin

Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.

Aspirin

Intervention Type DRUG

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.

Thienopyridine

Intervention Type DRUG

Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Interventions

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Aspirin

Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Intervention Type DRUG

Thienopyridine

Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teikyo University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ken Kozuma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Teikyo University Hospital

Locations

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Teikyo University Hospital

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Ken Kozuma, MD, PhD

Role: CONTACT

+81-3-3964-1211

Facility Contacts

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Ken Kozuma, MD, PhD

Role: primary

+81-3-3964-1211

Other Identifiers

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MODEL U-SES

Identifier Type: -

Identifier Source: org_study_id

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