Clinical trial NCT02837003: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Drug-Eluting Stent
Lead sponsor: Teikyo University
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 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).
timeFrame: 12-month
Secondary outcomes:
measure: 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).
timeFrame: 3-month
measure: Major adverse cardiac event
timeFrame: 3-month
measure: Major adverse cardiac event
timeFrame: 12-month
measure: All cause death
timeFrame: 3-month
measure: All cause death
timeFrame: 12-month
measure: Cardiac death
timeFrame: 3-month
measure: Cardiac death
timeFrame: 12-month
measure: Myocardial infarction
timeFrame: 3-month
measure: Myocardial infarction
timeFrame: 12-month
measure: Stroke (ischemic and hemorrhagic)
timeFrame: 3-month
measure: Stroke (ischemic and hemorrhagic)
timeFrame: 12-month
measure: Target lesion revascularization
timeFrame: 3-month
measure: Target lesion revascularization
timeFrame: 12-month
measure: Target vessel revascularization
timeFrame: 3-month
measure: Target vessel revascularization
timeFrame: 12-month
measure: Readmission related to angina
timeFrame: 3-month
measure: Readmission related to angina
timeFrame: 12-month
measure: Stent thrombosis
timeFrame: 3-month
measure: Stent thrombosis (ARC definition)
timeFrame: 12-month
measure: Bleeding complications (BARC definition)
timeFrame: 3-month
measure: Bleeding complications (BARC definition)
timeFrame: 12-month
measure: Comparison of event rate by the type of antiplatelet agent
timeFrame: 12-month
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Teikyo University Hospital
Study officials:
affiliation: Teikyo University Hospital
name: Ken Kozuma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: