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

Completed

Phase 4 Results

Trial Description

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.

Conditions

Interventions

  • Pradaxa (dabigatran etexilate) Drug
    Intervention Desc: 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
    ARM 1: Kind: Experimental
    Label: Pradaxa (dabigaran etexilate)
    Description: 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: Kind: Experimental
    Label: Pradaxa and pantoprazole
    Description: 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
  • Pradaxa, within 30 minutes after a meal Drug
    Intervention Desc: Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal
    ARM 1: Kind: Experimental
    Label: Pradaxa, 30 minutes after a meal
    Description: 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
  • Pantoprazole Drug
    Intervention Desc: 40 mg q.a.m, p.o.
    ARM 1: Kind: Experimental
    Label: Pradaxa and pantoprazole
    Description: 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

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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. 4 weeks No
Primary Number of participants with adverse events Up to 5.5 months Yes
Secondary The proportion of patients experiencing complete, partial, or complete or partial effectiveness on gastrointestinal symptoms (GIS) at each week (other than week 4). 4 and 8 weeks No
Secondary Time between symptom onset and first observed complete or partial effectiveness 4 and 8 weeks No
Secondary Time between symptom onset and last observed symptom 4 and 8 weeks No
Primary Bleeding and other adverse events reported by patients and/or observed by Investigators Up to 5.5 months Yes
Primary The Rate of Complete Effectiveness of Initial GIS Management Strategy Week 4 No
Secondary Rate of Partial Effectiveness of Initial GIS Management Strategies Week 4 No
Secondary Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies Week 4 No
Secondary Rate of Complete Effectiveness of Combined GIS Management Strategies Week 8 No
Secondary Rate of Partial Effectiveness of Combined GIS Management Strategies Week 8 No
Secondary Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies Week 8 No
Secondary Rates of Complete Effectiveness of GIS at Each Visit. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 No
Secondary Rates of Partial Effectiveness of GIS at Each Visit. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 No
Secondary Rates of Complete or Partial Effectiveness of GIS at Each Visit. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 No
Secondary Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom Week 8 No

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