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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   Efficacy and safety of once-daily oral Rivaroxaban (BAY 59-7939) compared w/dose-adjusted oral Vitamin K Antagonist (VKA) for the prevention of cardiovascular events in subjects w/nonvalvular atrial fibrillation scheduled for Cardioversion
Description   The purpose of this study is to see if Rivaroxaban, a new blood thinner, is effective and safe if it is taken before and after Cardioversion. (Cardiology)
IRB Number   Pro4405
Inclusion/Notes   INCLUSION:
  • Men or women aged = 18 years.

  • Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration.

  • Scheduled for cardioversion (electrical or harmacological) of nonvalvular atrial fibrillation.

  • Written informed consent.

  • Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent
    form until 30 days after the last study drug administration. The definition of adequate contraception will be based on the judgment of the investigator and local requirements.
    Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intrauterine device; and (iv) hormone-based contraception.

EXCLUSION:
  • Severe, disabling stroke (modified Rankin score of 4.5, inclusive; see Section 14.2) within 3 months or any stroke within 14 days before the randomization visit.

  • Transient ischemic attack within 3 days prior to randomization.

  • Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization.

  • Acute MI within the last 14 days prior to randomization.

  • Cardiac-related criteria:
    - Known presence of left atrial/LAA thrombus before study inclusion.
    - Known presence of atrial myxoma.
    - Known left ventricular or aortic thrombus.
    - Valvular heart disease (either hemodynamically significant mitral valve stenosis or prosthetic heart valve).
    - Active bleeding or high risk for bleeding contraindicating anticoagulant therapy.

  • Concomitant drugs/therapies:
    - Indication for anticoagulant therapy for a condition other than atrial fibrillation (eg, VTE).
    - Chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy.
    - Concomitant use of strong inhibitors of both cytochrome P450 (CYP)-3A4 and P-glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotic agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically.

  • Concomitant conditions:
    - Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding.
    - Hypersensitivity to investigational treatment or comparator treatment.
    - Calculated CrCl < 30 mL/minute (see Section 14.1).
    - Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
    - Any severe condition that would limit life expectancy to less than 6 months (eg, advanced malignancy, etc.).
    - Planned invasive procedure with potential for uncontrolled bleeding, including major surgery or cardiac catheterization Inability to take oral medication.
    - Ongoing drug addiction or alcohol abuse.

  • Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment.

  • Participation in a study with an investigational drug or medical device within 30 days prior to randomization.

  • Previous randomization in this study.

  • Inability to cooperate with the study procedures.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Jorge Cheirif MD
Contact Name   Alexa LeBlanc
Phone   (214) 361-3441

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