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Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk

NCT ID: NCT02960126

Last Updated: 2016-11-09

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

PHASE3

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-10-31

Brief Summary

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This study was designed in order to evaluate and compare the efficacy and safety between aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).

Detailed Description

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Efficacy outcome will be evaluated the major cerebro-cardiovascular event including stroke, cardiovascular death, and myocardial infarction during 1 year-medication period. In addition, safety outcome will be evaluated the gastrointestinal responses including peptic ulcer and upper gastrointestinal bleeding events to both study drugs by repeated gastroenteroscopic examinations before and after medication by GI specialist.

Conditions

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Atrial Fibrillation

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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Intervention: Clopidogrel

Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Control: Aspirin

Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Interventions

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Aspirin

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Man or Women \> 20 years old
2. newly detected AF (CHA2DS2VASc index score: 1)
3. Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
4. volunteer only
5. childbearing aged women who takes proper oral contraceptive

Exclusion Criteria

1. No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
2. Patient with active GI bleeding or bleeding tendency or major bleeding history
3. less than 1 year of residual expected life
4. Pregnant or breast-feeding women
5. Other causes, determined by charged physician
6. Patient with definite GERD who needs special treatment
7. Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Min Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Park SM, Jeong H, Jung MH, Hong KS, Hong MK, Bang CS, Kim CY. Rationale and Design for a Randomized Comparison of Efficacy and Safety between Aspirin and Clopidogrel in Atrial Fibrillation Patients with Low Stroke Risk: CESAC-AF trial. Contemp Clin Trials. 2017 Sep;60:51-55. doi: 10.1016/j.cct.2017.06.011. Epub 2017 Jun 19.

Reference Type DERIVED
PMID: 28642210 (View on PubMed)

Other Identifiers

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CESAC-AF

Identifier Type: -

Identifier Source: org_study_id