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

• The proportion (comparative rate) of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg q.a.m. vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Number of participants with adverse events [ Time Frame: Up to 5.5 months ] [ Designated as safety issue: Yes ]

• The proportion of patients experiencing complete, partial, or complete or partial effectiveness on gastrointestinal symptoms (GIS) at each week (other than week 4). [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
• Time between symptom onset and first observed complete or partial effectiveness [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
• Time between symptom onset and last observed symptom [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

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 12 months prior to enrolment. Approximately 60 - 80 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.

• Drug: pantoprazole
  40 mg q.a.m, p.o.
• Drug: Pradaxa (dabigatran etexilate)
  150 mg or 75 mg b.i.d.
• Drug: Pradaxa, within 30 minutes after a meal
  Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal

• Pradaxa (dabigaran etexilate)
  Patients with non valvular atrial fibrillation for whom Pradaxa is indicated in accordance with the current local label, not previously treated with Pradaxa, will be provided 3 months of treatment for the prevention of stroke and systemic embolism. Patients who report gastrointestinal symptoms (GIS) will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
  Intervention: Drug: Pradaxa (dabigatran etexilate)
• Active Comparator: Pradaxa and pantoprazole
  Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal
  Interventions:

  • Drug: pantoprazole
  • Drug: Pradaxa (dabigatran etexilate)
• Active Comparator: Pradaxa, 30 minutes after a meal
  Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal
  Intervention: Drug: Pradaxa, within 30 minutes after a meal

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 one year of any of the following gastrointestinal (GI) disorders: dyspepsia, abdominal pain or discomfort, heartburn, indigestion, nausea, vomiting, gastritis, gastroesophageal reflux, or of use of proton pump inhibitors, histamine-2 receptor blockers or antacids.
2. GI bleeding within the past 2 years 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. Any history of symptomatic or endoscopically documented gastroduodenal ulcer, or diverticulitis
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, 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 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