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

November 8, 2016 updated by: Sang Min Park, Chuncheon Sacred Heart Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention: Clopidogrel
Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Drug: Clopidogrel
Experimental: Control: Aspirin
Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Drug: Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Time Frame: 1 year after randomization
Number of each event
1 year after randomization
Major gastrointestinal event including peptic ulcer disease and bleeding
Time Frame: 1 year after randomization
Number of each event
1 year after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CESAC-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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