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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

NCT01493557 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1067

Last updated 2015-10-05

Study results available
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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.

Conditions

Interventions

DRUG

pantoprazole

40 mg q.a.m, p.o.

DRUG

Pradaxa (dabigatran etexilate)

150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

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

DRUG

Pradaxa (dabigatran etexilate)

150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493557 on ClinicalTrials.gov