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
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Atrial Fibrillation |
| Intervention | Drug: pantoprazole Drug: Pradaxa (dabigatran etexilate) Drug: Pradaxa, within 30 minutes after a meal Drug: Pradaxa (dabigatran etexilate) |
| Phase | Phase 4 |
| Sponsor | Boehringer Ingelheim |
| Responsible Party | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier | NCT01493557 |
| First Received | December 12, 2011 |
| Last Updated | April 16, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 12, 2011 |
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| Last Updated Date | April 16, 2014 |
| Start Date | December 2011 |
| Estimated Primary Completion Date | July 2014 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
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| 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) |
| 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 | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention |
| Condition | Atrial Fibrillation |
| Intervention | 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. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1200 |
| Estimated Completion Date | July 2014 |
| Estimated Primary Completion Date | July 2014 |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01493557 |
|---|---|
| Other Study ID Numbers | 1160.128 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Boehringer Ingelheim |
| Study Sponsor | Boehringer Ingelheim |
| Collaborators | Not Provided |
| Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| 1160.128.1160 Boehringer Ingelheim Investigational Site | Calgary, Alberta, Canada Recruiting |
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| 1160.128.1159 Boehringer Ingelheim Investigational Site | Edmonton, Alberta, Canada Recruiting |
| 1160.128.1152 Boehringer Ingelheim Investigational Site | Red Deer, Alberta, Canada Recruiting |
| 1160.128.1153 Boehringer Ingelheim Investigational Site | Spruce Grove, Alberta, Canada Recruiting |
| 1160.128.1167 Boehringer Ingelheim Investigational Site | Coquitlam, British Columbia, Canada Recruiting |
| 1160.128.1158 Boehringer Ingelheim Investigational Site | Victoria, British Columbia, Canada Recruiting |
| 1160.128.1154 Boehringer Ingelheim Investigational Site | Saint John, New Brunswick, Canada Recruiting |
| 1160.128.1166 Boehringer Ingelheim Investigational Site | Bay Roberts, Newfoundland and Labrador, Canada Recruiting |
| 1160.128.1151 Boehringer Ingelheim Investigational Site | Brampton, Ontario, Canada Recruiting |
| 1160.128.1168 Boehringer Ingelheim Investigational Site | Cambridge, Ontario, Canada Recruiting |
| 1160.128.1164 Boehringer Ingelheim Investigational Site | Collingwood, Ontario, Canada Recruiting |
| 1160.128.1173 Boehringer Ingelheim Investigational Site | Corunna, Ontario, Canada Recruiting |
| 1160.128.1156 Boehringer Ingelheim Investigational Site | Hamilton, Ontario, Canada Recruiting |
| 1160.128.1157 Boehringer Ingelheim Investigational Site | Kitchener, Ontario, Canada Recruiting |
| 1160.128.1155 Boehringer Ingelheim Investigational Site | London, Ontario, Canada Recruiting |
| 1160.128.1170 Boehringer Ingelheim Investigational Site | Peterborough, Ontario, Canada Recruiting |
| 1160.128.1169 Boehringer Ingelheim Investigational Site | Sarnia, Ontario, Canada Recruiting |
| 1160.128.1165 Boehringer Ingelheim Investigational Site | Sarnia, Ontario, Canada Recruiting |
| 1160.128.1161 Boehringer Ingelheim Investigational Site | Stayner, Ontario, Canada Recruiting |
| 1160.128.1171 Boehringer Ingelheim Investigational Site | Sudbury, Ontario, Canada Recruiting |
| 1160.128.1162 Boehringer Ingelheim Investigational Site | Toronto, Ontario, Canada Recruiting |
| 1160.128.1172 Boehringer Ingelheim Investigational Site | Saskatoon, Saskatchewan, Canada Recruiting |