Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Drug: P2Y12 antagonist monotherapy; Drug: aspirin plus P2Y12 antagonist

• Registration Number: NCT02079194
• Lead Sponsor: Samsung Medical Center

Brief Summary

To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.

Detailed Description

This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Study Start: 2014-03-18
• Primary Completion: 2018-07-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Study Completion: 2020-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Subject must be at least 20 years of age.
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Patients undergoing successful PCI

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Exclusion Criteria

• Hemodynamic instability or cardiogenic shock
• Active bleeding
• Known hypersensitivity or contraindication to study medications
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
• Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• DES implantation within 12 months before index procedure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P2Y12 antagonist monotherapy	P2Y12 antagonist monotherapy	P2Y12 antagonist monotherapy after 3-month DAPT
Aspirin + P2Y12 antagonist	aspirin plus P2Y12 antagonist	Aspirin + P2Y12 antagonist after 3-month DAPT

Primary Outcome Measures

Name	Time	Method
A composite of death, myocardial infarction, or cerebrovascular events	1 year	12 months after the index procedure

Secondary Outcome Measures

Name	Time	Method
All cause Death	1 years
cardiac death	1 years
Myocardial infarction (MI)	1 years
BARC bleeding ≥2	1 years
Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization	1 years
Stent thrombosis: definite or probable stent thrombosis by ARC definition	1 years
Target vessel revascularization (TVR)	1 years
Cerebrovascular accident (CVA)	1 years
Any revascularization	1 years
BARC bleeding ≥3	1 years
Target lesion revascularization (TLR)	1 years

Trial Locations

Locations (1)

Cardiac and Vascular Center; Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of