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

Phase 3

• Conditions: Atrial Fibrillation
• Interventions: Drug: Aspirin; Drug: Clopidogrel

• Registration Number: NCT02960126
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Study First Posted: 2016-11-09
• Last Update Posted: 2016-11-09
• Primary Completion: 2020-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Aspirin	Aspirin	Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Intervention: Clopidogrel	Clopidogrel	Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.

Primary Outcome Measures

Name	Time	Method
Major Cerebrovascular and cardiac events including stroke, CV death, MI	1 year after randomization	Number of each event
Major gastrointestinal event including peptic ulcer disease and bleeding	1 year after randomization	Number of each event