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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Atrial Fibrillation
Title   A Long Term Multi-Center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation (Heart/Atrial Fibrillation)
Description   Atrial fibrillation (AF) is an irregular heartbeat that can cause blood clots to form in the heart. These clots can break away and block other blood vessels. If the clot blocks an artery in the brain it can cause a stroke. The chance of a stroke is increased if other diseases or conditions are present including coronary artery disease, high blood pressure, diabetes, heart failure, a previous heart attack or a previous stroke including transient ischemic attacks.
The RE-LY study tested an investigational blood thinning drug, dabigatran etexilate, to see if it would prevent strokes as well as warfarin. This study, RELY-ABLE (an extension study of RE-LY), will test the long-term safety of two dose levels of dabigatran etexilate and will test whether giving customized feedback to subjects and study doctors will improve the health status of the subjects with AF.
IRB Number   Pro2104
Inclusion/Notes   INCLUSION:
  • Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation.

EXCLUSION:
  • Need for anticoagulant treatment for disorders other than atrial fibrillation.

  • Active infective endocarditis.

  • Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.

  • Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study.

  • Current use of quinidine.
Status   Completed
Location   Texas Health Research & Education Institute
Principal Name    Theodore Sunao Takata MD
Contact Name   Tracie Bruton
Phone   (817) 820-4956

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