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

Atrial Fibrillation Clinical Trial

— CESAC-AF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02960126
• Other study ID #: CESAC-AF
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 2, 2016
• Last updated: November 8, 2016
• Start date: November 2016
• Est. completion date: October 2021

Study information

• Verified date: November 2016
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 100 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Aspirin

• Clopidogrel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Cerebrovascular and cardiac events including stroke, CV death, MI	Number of each event	1 year after randomization	No
Primary	Major gastrointestinal event including peptic ulcer disease and bleeding	Number of each event	1 year after randomization	Yes