Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES

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

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-18

Study Completion Date

2020-07-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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P2Y12 antagonist monotherapy

P2Y12 antagonist monotherapy after 3-month DAPT

Group Type EXPERIMENTAL

P2Y12 antagonist monotherapy

Intervention Type DRUG

Aspirin + P2Y12 antagonist

Aspirin + P2Y12 antagonist after 3-month DAPT

Group Type EXPERIMENTAL

aspirin plus P2Y12 antagonist

Intervention Type DRUG

Interventions

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P2Y12 antagonist monotherapy

Intervention Type DRUG

aspirin plus P2Y12 antagonist

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No