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

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. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole,
lansoprazole, rabeprazole, atnoprazole, esomeprazole

4. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to
Pradaxa® (dabigatran etexilate) or its excipients

5. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding

6. Need for anticoagulant treatment for disorders other than atrial fibrillation

7. Current treatment with rifampin

8. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal
replacement therapy (dialysis)

9. 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.

10. Patients who have received an investigational drug in the past 30 days or are
participating in another drug study

11. Patients considered unreliable by the investigator concerning the requirements for
follow-up during the study

12. Any condition the investigator believes would not allow safe participation in the
study

13. 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.