Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk (CESAC-AF)

Chuncheon Sacred Heart Hospital

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Clopidogrel; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02960126

CESAC-AF

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Intervention: Clopidogrel

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel

Control: Aspirin

Experimental group

Description:

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

Treatment:

Drug: Aspirin