A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Embolism
Intervention: pantoprazole; Pradaxa (dabigatran etexilate); Pradaxa, within 30 minutes after a meal; Pradaxa (dabigatran etexilate)
Intervention description: 40 mg q.a.m, p.o.; 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada); Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal; 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
Intervention MeSH terms: Pantoprazole; Dabigatran
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1067.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective and open label study that aims to enroll approximately 1200 patients
      with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of
      gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125
      sites in North America will be recruited. Patients who report GIS during the 3 month
      treatment period will be randomized to one of two management strategies, and data documenting
      the intensity and duration of the GIS will be collected.
    

Eligibility criteria:

        Inclusion criteria:

          1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran
             etexilate) is indicated per the current local label, but who have not received
             treatment with Pradaxa® (dabigatran etexilate), or who have not been started on
             Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the
             study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/
             implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring

          2. Male and female patients, age greater than or equal to 18 years at entry

          3. Written, informed consent

        Exclusion criteria:

          1. History within 2 weeks of any of the following gastrointestinal (GI) disorders:
             heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or
             gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2
             receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks
             are not excluded if the symptoms were clearly associated with a self-limited acute or
             febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the
             prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium
             replacement is not exclusionary (as long as these products are being used as calcium
             supplementation/replacement and are not being used to treat or relieve GIS.)

          2. GI bleeding within one year or any history of symptomatic or endoscopically documented
             gastroduodenal ulcer or diverticulitis, unless the cause has been permanently
             eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease
             with endoscopically proven cure after therapy or lower GI bleeding due to
             diverticulosis cured by segmental colectomy are not excluded.)

          3. not applicable

          4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole,
             lansoprazole, rabeprazole, atnoprazole, esomeprazole

          5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to
             Pradaxa® (dabigatran etexilate) or its excipients

          6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding

          7. Need for anticoagulant treatment for disorders other than atrial fibrillation

          8. Current treatment with rifampin

          9. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal
             replacement therapy (dialysis)

         10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed
             consent) who: are nursing or pregnant, or are of child bearing potential and are not
             practicing an acceptable method of birth control, or do not plan to continue using
             this method throughout the study. Acceptable methods of birth control include
             abstinence, tubal ligation, transdermal patch, intra uterine devices/systems
             (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and
             vasectomized partner.

         11. Patients who have received an investigational drug in the past 30 days or are
             participating in another drug study

         12. Patients considered unreliable by the investigator concerning the requirements for
             follow-up during the study

         13. Any condition the investigator believes would not allow safe participation in the
             study

         14. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the
             setting of other forms of valvular heart disease, including the presence of a
             bio-prosthetic valve, is not recommended.