Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation

NCT03839355

Last updated date
Study Location
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Non-valvular Atrial Fibrillation

- CHA2DS2-VASc Score > or = to 2

- Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month

- Candidate for oral anticoagulation as assessed by a treating physician

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral
stenosis,Mechanical cardiac valve)


- Active Bleeding


- Prior treatment with Apixaban >1 month


- Recent stroke within 7 days


- Dementia


- Implanted devices not compatible with MRI/any cardiac implanted device


- Claustrophobia


- Active alcohol/drug abuse


- Life expectancy < 1 year


- Taking asprin with >100mg doses


- Known hypersensitivity to warfarin or Apixaban


- Severe renal insufficiency


- Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal
bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring
transfusion)


- Psychosocial reasons that make study participation impractical


- Currently enrolled in another IND or IDE trial that has not completed the primary
endpoint or that clinically interferes with the current study endpoints


- Co-morbid condition(s) that could limit the subject's ability to participate in the
trial or to comply with follow-up requirements, or that could impact the scientific
integrity of the study.


- Prisoners or subjects who are involuntarily incarcerated


- Subjects who are compulsorily detained for treatment of either psychiatric or physical
illness


- Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp
(Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole,
itraconazole, ritonavir, clarithromycin)


- Need for dual anti-platelet therapy with aspirin and another agent such as
thienopyridine

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Atrial FibrillationIntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4
NCT01740037
  1. Groningen,
  2. Groningen,
  3. Haarlem,
  4. Leeuwarden,
  5. Maastricht,
  6. Nijmegen,
  7. Zaandam,
  8. Zwolle,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Atrial FibrillationEvaluation of Safety and Effectiveness on Oral Anticoagulants
NCT03765242
  1. Minato-ku, Tokyo
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Atrial FibrillationAmiodarone to Prevent Post-Operative Arrhythmias
NCT00251706
  1. Calgary, Alberta
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
Official Title  ICMJE Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2
Brief Summary The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin. The investigators also hypothesize that Apixaban reduces cognitive decline by reducing the rate of new cerebral infarction and cerebral microbleeds detected by cerebral MRI compared to warfarin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Apixaban
    Dosage either 5mg or 2.5mg for 2 years
    Other Name: Eliquis
  • Drug: Warfarin
    Dosage assessed by your treating physician for 2 years
    Other Name: Coumadin
Study Arms  ICMJE
  • Active Comparator: Eliquis
    Intervention: Drug: Apixaban
  • Active Comparator: Warfarin
    Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-valvular Atrial Fibrillation
  • CHA2DS2-VASc Score > or = to 2
  • Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month
  • Candidate for oral anticoagulation as assessed by a treating physician

Exclusion Criteria:

  • Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
  • Active Bleeding
  • Prior treatment with Apixaban >1 month
  • Recent stroke within 7 days
  • Dementia
  • Implanted devices not compatible with MRI/any cardiac implanted device
  • Claustrophobia
  • Active alcohol/drug abuse
  • Life expectancy < 1 year
  • Taking asprin with >100mg doses
  • Known hypersensitivity to warfarin or Apixaban
  • Severe renal insufficiency
  • Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring transfusion)
  • Psychosocial reasons that make study participation impractical
  • Currently enrolled in another IND or IDE trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  • Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the study.
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
  • Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole, itraconazole, ritonavir, clarithromycin)
  • Need for dual anti-platelet therapy with aspirin and another agent such as thienopyridine
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03839355
Other Study ID Numbers  ICMJE 17-010544
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Malini Madhavan, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • Pfizer
  • Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator:Malini MadhavanMayo Clinic
PRS Account Mayo Clinic
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP