Atrial FibrillationPhase 4GIRAFNCT01994265
Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
A Phase 4 study testing Warfarin and Dabigatran in people with Atrial Fibrillation, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF patients, despite effective, remains beyond desired levels because of interactions with food and fluctuations in blood levels. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Warfarin and Dabigatran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesBrazil
- Study dates
- 7 Nov 2014to 9 Mar 2021
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Atrial fibrillation
- CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk (CHADS2VASc) greater than 1
Who cannot join
- Heart valve disease
- Previous Stroke or Transient ischemic attack
- Cognitive impairment or any severe neurological disorder
- Major surgery in the last 30 days
- Planned elective surgery in the next three months
- Intracranial, ocular, spinal, retroperitoneal, or articular bleeding without trauma.
Show all 19Show fewer
- Gastrointestinal bleeding in the last 12 months
- Symptomatic gastric ulcer
- Hemorrhagic disease
- Use of thrombolytics
- Uncontrolled hypertension
- Active cancer
- Contraindication for Warfarin use
- Reversible causes of atrial fibrillation
- Creatinine clearance < 30 ml/min
- Active endocarditis
- Active hepatitis
- Severe anemia
- Left ventricle ejection fraction < 35%
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Federal Univeristy of Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
Heart Institute - University of São Paulo
São Paulo, 05403-000
About this study
Official title: Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF patients, despite effective, remains beyond desired levels because of interactions with food and fluctuations in blood levels. Because of a more stable anticoagulation state, Dabigatran may offer better protection against thrombotic phenomenon and, consequently, mitigate the process of cognitive and functional compromise.
Read the detailed description
This will be a prospective parallel study including two hundred atrial fibrillation patients > 65 years old and scoring CHADS2VASc > 1. Patients will be randomized to receive Warfarin (INR between 2 and 3) or Dabigatran (150 mg twice daily) for two years. After one year and at the end of the study, individuals will be evaluated regarding cognitive endpoints following the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards (Hachinski et al. Stroke 2006;37:2220-2241). The investigators will use the 60 minutes evaluation protocol complemented by the Montreal Cognitive Assessment (MoCA).
- Conditions
- Atrial Fibrillation
- Being tested
- Warfarin, Dabigatran
- Keywords
- Atrial fibrillation, Cognition, Cognitive impairment, Anticoagulation, Dabigatran, Warfarin, Efficacy
- Medical subject headings
- Atrial Fibrillation, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Marevan, Coumadin
Warfarin once daily, at fast, targeting INR between 2 and 3
DabigatranDrug
Also called Dabigatran 150 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Active comparator | Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3. Receives: Drug: Warfarin |
| Dabigatran | Active comparator | Dabigatran 150 mg twice daily Receives: Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
Measured: Two years
Secondary outcomes (1)
Number of Participants with less important alteration in coagulation test as a Measure of Safety
Comparison of thrombin generation test between the two treatment groups.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start7 Nov 2014
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais, Boehringer Ingelheim
- Responsible party
- Principal investigator, Bruno Caramelli, University of Sao Paulo
- Investigators
- Bruno Caramelli, Professor, Principal investigator, Heart Institute, University of Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994265
- Sponsor's protocol ID
- USP/UFMG 2013
- Acronym
- GIRAF
- Status last verified
- Sep 2021
- First submitted
- 9 Nov 2013
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caramelli B, Yu PC, Cardozo FAM, Magalhaes IR, Spera RR, Amado DK, Escalante-Rojas MC, Gualandro DM, Calderaro D, Tavares CAM, Borges-Junior FA, Pastana AF, Matheus MG, Brucki SMD, Rodrigues ACO, Nitrini R, Caramelli P. Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial. BMC Med. 2022 Oct 26;20(1):374. doi: 10.1186/s12916-022-02563-2.
PubMed 36284318
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
- ClinicalTrials.gov ID
- NCT01994265
- Acronym / sponsor ID
- GIRAF / USP/UFMG 2013
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Cognition, Cognitive impairment, Anticoagulation, Dabigatran, Warfarin, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais, Boehringer Ingelheim
- Study start
- 7 Nov 2014
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 25 Nov 2013 (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.
Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF patients, despite effective, remains beyond desired levels because of interactions with food and fluctuations in blood levels. Because of a more stable anticoagulation state, Dabigatran may offer better protection against thrombotic phenomenon and, consequently, mitigate the process of cognitive and functional compromise.
Detailed description
This will be a prospective parallel study including two hundred atrial fibrillation patients > 65 years old and scoring CHADS2VASc > 1. Patients will be randomized to receive Warfarin (INR between 2 and 3) or Dabigatran (150 mg twice daily) for two years. After one year and at the end of the study, individuals will be evaluated regarding cognitive endpoints following the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards (Hachinski et al. Stroke 2006;37:2220-2241). The investigators will use the 60 minutes evaluation protocol complemented by the Montreal Cognitive Assessment (MoCA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Active comparator | Drug: WarfarinTreatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3. |
| Dabigatran | Active comparator | Drug: DabigatranDabigatran 150 mg twice daily |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Atrial fibrillation
- CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk (CHADS2VASc) greater than 1
Key exclusion criteria (19 listed)
- Heart valve disease
- Previous Stroke or Transient ischemic attack
- Cognitive impairment or any severe neurological disorder
- Major surgery in the last 30 days
- Planned elective surgery in the next three months
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 |
|---|---|---|
| WarfarinAlso: Marevan, CoumadinWarfarin once daily, at fast, targeting INR between 2 and 3 | Drug | Warfarin |
| DabigatranAlso: Dabigatran 150 mg twice daily | Drug | Dabigatran |
Primary outcome
Cognitive impairment
Time frame: Two years
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
1 secondary outcome
Number of Participants with less important alteration in coagulation test as a Measure of Safety
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 36284318Caramelli B, Yu PC, Cardozo FAM, Magalhaes IR, Spera RR, Amado DK, Escalante-Rojas MC, Gualandro DM, Calderaro D, Tavares CAM, Borges-Junior FA, Pastana AF, Matheus MG, Brucki SMD, Rodrigues ACO, Nitrini R, Caramelli P. Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial. BMC Med. 2022 Oct 26;20(1):374. doi: 10.1186/s12916-022-02563-2.
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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.
Bruno Caramelli, Professor principal investigator
Heart Institute, University of Sao Paulo, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin and Dabigatran in people with Atrial Fibrillation, run by University of Sao Paulo at 2 sites in Brazil.
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 2 inclusion and 19 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: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive impairment (time frame: Two years). 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 NCT01994265, 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 29 Sep 2021.