Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1067
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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 arm 3: 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: intervention 1: pantoprazole intervention 2: Pradaxa (dabigatran etexilate) intervention 3: Pradaxa, within 30 minutes after a meal intervention 4: Pradaxa (dabigatran etexilate)
Intervention descriptions: intervention 1: 40 mg q.a.m, p.o. intervention 2: 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada) intervention 3: Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal intervention 4: 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

Protocol document: