At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa® With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa® 150 mg b.i.d., 110 mg b.i.d. or 75 mg b.i.d. for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (NVAF)
In Brief
A Phase 4 clinical trial evaluating pantoprazole, Pradaxa (dabigatran etexilate), and 1 other intervention for Atrial Fibrillation. Completed, enrolled 1,067 participants across 103 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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)