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

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01493557

Run by

Boehringer Ingelheim

People needed

1067

Starts

2011-12-01

Expected to finish

2014-07-01

Last updated by the study team

2015-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Male and female patients, age greater than or equal to 18 years at entry
• Written, informed consent

You may not qualify if…

• 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.)
• 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.)
• not applicable
• Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole
• Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients
• Hemorrhagic disorder, bleeding diathesis or active pathological bleeding
• Need for anticoagulant treatment for disorders other than atrial fibrillation
• Current treatment with rifampin
• Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis)
• 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 abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner.
• Patients who have received an investigational drug in the past 30 days or are participating in another drug study
• Patients considered unreliable by the investigator concerning the requirements for follow-up during the study
• Any condition the investigator believes would not allow safe participation in the study
• 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.

Where it is running

• 1160.128.1045 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 1160.128.1003 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1160.128.1093 Boehringer Ingelheim Investigational Site — Chandler, Arizona, United States
• 1160.128.1067 Boehringer Ingelheim Investigational Site — Hot Springs, Arkansas, United States
• 1160.128.1103 Boehringer Ingelheim Investigational Site — Mesa, California, United States
• 1160.128.1094 Boehringer Ingelheim Investigational Site — Newport Beach, California, United States
• 1160.128.1042 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1160.128.1005 Boehringer Ingelheim Investigational Site — Colorado Spring, Colorado, United States
• 1160.128.1023 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1160.128.1016 Boehringer Ingelheim Investigational Site — Bridgeport, Connecticut, United States
• 1160.128.1066 Boehringer Ingelheim Investigational Site — Bridgeport, Connecticut, United States
• 1160.128.1018 Boehringer Ingelheim Investigational Site — Guilford, Connecticut, United States
• 1160.128.1050 Boehringer Ingelheim Investigational Site — Norwalk, Connecticut, United States
• 1160.128.1057 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 1160.128.1085 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 1160.128.1111 Boehringer Ingelheim Investigational Site — Atlantis, Florida, United States
• 1160.128.1032 Boehringer Ingelheim Investigational Site — Brandon, Florida, United States
• 1160.128.1021 Boehringer Ingelheim Investigational Site — Coral Springs, Florida, United States
• 1160.128.1027 Boehringer Ingelheim Investigational Site — Daytona Beach, Florida, United States
• 1160.128.1019 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 1160.128.1062 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 1160.128.1054 Boehringer Ingelheim Investigational Site — Largo, Florida, United States
• 1160.128.1097 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1160.128.1109 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1160.128.1046 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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