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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01493557
First received: December 12, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: pantoprazole
Drug: Pradaxa (dabigatran etexilate)
Drug: Pradaxa, within 30 minutes after a meal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Bleeding and other adverse events reported by patients and/or observed by Investigators [ Time Frame: Up to 5.5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of patients experiencing complete, partial, or complete or partial effectiveness on gastrointestinal symptoms (GIS) at each week (other than week 4). [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Time between symptom onset and first observed complete or partial effectiveness [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Time between symptom onset and last observed symptom [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 1067
Study Start Date: December 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pradaxa (dabigaran etexilate)
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.
Drug: Pradaxa (dabigatran etexilate)
150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
Active Comparator: Pradaxa and pantoprazole
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
Drug: pantoprazole
40 mg q.a.m, p.o.
Drug: Pradaxa (dabigatran etexilate)
150 mg or 75 mg b.i.d.
Active Comparator: Pradaxa, 30 minutes after a meal
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. NA
  4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole
  5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients
  6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding
  7. Need for anticoagulant treatment for disorders other than atrial fibrillation
  8. Current treatment with rifampin
  9. Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis)
  10. 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 tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner.
  11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
  12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study
  13. Any condition the investigator believes would not allow safe participation in the study
  14. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493557

  Show 103 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01493557     History of Changes
Other Study ID Numbers: 1160.128
Study First Received: December 12, 2011
Last Updated: August 20, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Dabigatran
Pantoprazole
Anti-Ulcer Agents
Anticoagulants
Antithrombins
Enzyme Inhibitors
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Proton Pump Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014