Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

NCT01994265 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-29

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

Warfarin

Warfarin once daily, at fast, targeting INR between 2 and 3

DRUG

Dabigatran

Sponsors & Collaborators

  • Federal University of Minas Gerais

    collaborator OTHER
  • Boehringer Ingelheim

    collaborator INDUSTRY
  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Bruno Caramelli, Professor · Heart Institute, University of Sao Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-07
Primary Completion
2021-03-09
Completion
2021-03-09

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994265 on ClinicalTrials.gov