Atrial FibrillationPhase 3CESAC-AFNCT02960126
Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
A Phase 3 study testing Aspirin and Clopidogrel in people with Atrial Fibrillation, run by Chuncheon Sacred Heart Hospital.
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). Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or Women > 20 years old
- newly detected AF (CHA2DS2VASc index score: 1)
- Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
- volunteer only
- childbearing aged women who takes proper oral contraceptive
Who cannot join
- No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
- Patient with active GI bleeding or bleeding tendency or major bleeding history
- less than 1 year of residual expected life
- Pregnant or breast-feeding women
- Other causes, determined by charged physician
- Patient with definite GERD who needs special treatment
- Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks
About this study
Official title: 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).
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Aspirin, Clopidogrel
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Clopidogrel | Active comparator | Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient. Receives: Drug: Clopidogrel |
| Control: Aspirin | Experimental | Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Number of each event
Measured: 1 year after randomization
Major gastrointestinal event including peptic ulcer disease and bleeding
Number of each event
Measured: 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Min Park, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960126
- Sponsor's protocol ID
- CESAC-AF
- Acronym
- CESAC-AF
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28642210
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
- ClinicalTrials.gov ID
- NCT02960126
- Acronym / sponsor ID
- CESAC-AF / CESAC-AF
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Clopidogrel | Active comparator | Drug: ClopidogrelCase management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient. |
| Control: Aspirin | Experimental | Drug: AspirinUsual care with aspirin 100mg once daily is provided for stroke prevention in AF patient. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or Women > 20 years old
- newly detected AF (CHA2DS2VASc index score: 1)
- Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
- volunteer only
- childbearing aged women who takes proper oral contraceptive
Key exclusion criteria (7 listed)
- No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
- Patient with active GI bleeding or bleeding tendency or major bleeding history
- less than 1 year of residual expected life
- Pregnant or breast-feeding women
- Other causes, determined by charged physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin | Drug | Control: Aspirin |
| Clopidogrel | Drug | Intervention: Clopidogrel |
Primary outcome
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Time frame: 1 year after randomization
Number of each event
Major gastrointestinal event including peptic ulcer disease and bleeding
Time frame: 1 year after randomization
Number of each event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Derived from this study: PubMed 28642210Park 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin and Clopidogrel in people with Atrial Fibrillation, run by Chuncheon Sacred Heart Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cerebrovascular and cardiac events including stroke, CV death, MI (time frame: 1 year after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.