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

Condition(s) targeted: Atrial Fibrillation

Intervention: pantoprazole (Drug); Pradaxa (dabigatran etexilate) (Drug); Pradaxa, within 30 minutes after a meal (Drug); Pradaxa (dabigatran etexilate) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

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)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

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.

Bleeding and other adverse events reported by patients and/or observed by Investigators

Secondary outcome:

The proportion of patients experiencing complete, partial, or complete or partial effectiveness on gastrointestinal symptoms (GIS) at each week (other than week 4).

Time between symptom onset and first observed complete or partial effectiveness

Time between symptom onset and last observed symptom

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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. not applicable 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 abstinence, 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.

1160.128.1046 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

1160.128.1045 Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States

1160.128.1003 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States

1160.128.1160 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

1160.128.1159 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

1160.128.1152 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada

1160.128.1153 Boehringer Ingelheim Investigational Site, Spruce Grove, Alberta, Canada

1160.128.1093 Boehringer Ingelheim Investigational Site, Chandler, Arizona, United States

1160.128.1067 Boehringer Ingelheim Investigational Site, Hot Springs, Arkansas, United States

1160.128.1167 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada

1160.128.1158 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada

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, 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

1160.128.1087 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States

1160.128.1058 Boehringer Ingelheim Investigational Site, Pensacola, Florida, United States

1160.128.1007 Boehringer Ingelheim Investigational Site, Port Charlotte, Florida, United States

1160.128.1060 Boehringer Ingelheim Investigational Site, Rockledge, Florida, United States

1160.128.1096 Boehringer Ingelheim Investigational Site, Columbus, Georgia, United States

1160.128.1068 Boehringer Ingelheim Investigational Site, Roswell, Georgia, United States

1160.128.1076 Boehringer Ingelheim Investigational Site, Coeur d' Alene, Idaho, United States

1160.128.1073 Boehringer Ingelheim Investigational Site, Melrose Park, Illinois, United States

1160.128.1048 Boehringer Ingelheim Investigational Site, Winfield, Illinois, United States

1160.128.1105 Boehringer Ingelheim Investigational Site, Hammond, Indiana, United States

1160.128.1029 Boehringer Ingelheim Investigational Site, Indianapolis, Indiana, United States

1160.128.1079 Boehringer Ingelheim Investigational Site, Overland Park, Kansas, United States

1160.128.1008 Boehringer Ingelheim Investigational Site, Baton Rouge, Louisiana, United States

1160.128.1025 Boehringer Ingelheim Investigational Site, Auburn, Maine, United States

1160.128.1100 Boehringer Ingelheim Investigational Site, Biddeford, Maine, United States

1160.128.1041 Boehringer Ingelheim Investigational Site, Columbia, Maryland, United States

1160.128.1012 Boehringer Ingelheim Investigational Site, Salisbury, Maryland, United States

1160.128.1015 Boehringer Ingelheim Investigational Site, Rochester Hills, Michigan, United States

1160.128.1004 Boehringer Ingelheim Investigational Site, Tupelo, Mississippi, United States

1160.128.1014 Boehringer Ingelheim Investigational Site, Columbia, Missouri, United States

1160.128.1047 Boehringer Ingelheim Investigational Site, Kansas City, Missouri, United States

1160.128.1075 Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States

1160.128.1069 Boehringer Ingelheim Investigational Site, Great Falls, Montana, United States

1160.128.1011 Boehringer Ingelheim Investigational Site, Kalispell, Montana, United States

1160.128.1092 Boehringer Ingelheim Investigational Site, Lincoln, Nebraska, United States

1160.128.1059 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States

1160.128.1154 Boehringer Ingelheim Investigational Site, Saint John, New Brunswick, Canada

1160.128.1039 Boehringer Ingelheim Investigational Site, Elmer, New Jersey, United States

1160.128.1035 Boehringer Ingelheim Investigational Site, Flemington, New Jersey, United States

1160.128.1036 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States

1160.128.1063 Boehringer Ingelheim Investigational Site, Hawthorne, New York, United States

1160.128.1078 Boehringer Ingelheim Investigational Site, Mineola, New York, United States

1160.128.1001 Boehringer Ingelheim Investigational Site, Poughkeepsie, New York, United States

1160.128.1166 Boehringer Ingelheim Investigational Site, Bay Roberts, Newfoundland and Labrador, Canada

1160.128.1022 Boehringer Ingelheim Investigational Site, Asheville, North Carolina, United States

1160.128.1052 Boehringer Ingelheim Investigational Site, Gastonia, North Carolina, United States

1160.128.1071 Boehringer Ingelheim Investigational Site, Statesville, North Carolina, United States

1160.128.1091 Boehringer Ingelheim Investigational Site, Gallipolis, Ohio, United States

1160.128.1107 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

1160.128.1151 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada

1160.128.1168 Boehringer Ingelheim Investigational Site, Cambridge, Ontario, Canada

1160.128.1164 Boehringer Ingelheim Investigational Site, Collingwood, Ontario, Canada

1160.128.1173 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada

1160.128.1156 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada

1160.128.1157 Boehringer Ingelheim Investigational Site, Kitchener, Ontario, Canada

1160.128.1155 Boehringer Ingelheim Investigational Site, London, Ontario, Canada

1160.128.1170 Boehringer Ingelheim Investigational Site, Peterborough, Ontario, Canada

1160.128.1165 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada

1160.128.1169 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada

1160.128.1161 Boehringer Ingelheim Investigational Site, Stayner, Ontario, Canada

1160.128.1171 Boehringer Ingelheim Investigational Site, Sudbury, Ontario, Canada

1160.128.1162 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada

1160.128.1053 Boehringer Ingelheim Investigational Site, Bend, Oregon, United States

1160.128.1033 Boehringer Ingelheim Investigational Site, Hillsboro, Oregon, United States

1160.128.1037 Boehringer Ingelheim Investigational Site, Altoona, Pennsylvania, United States

1160.128.1034 Boehringer Ingelheim Investigational Site, Camp Hill, Pennsylvania, United States

1160.128.1010 Boehringer Ingelheim Investigational Site, Langhorne, Pennsylvania, United States

1160.128.1056 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States

1160.128.1065 Boehringer Ingelheim Investigational Site, Uniontown, Pennsylvania, United States

1160.128.1172 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada

1160.128.1043 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States

1160.128.1040 Boehringer Ingelheim Investigational Site, Rapid City, South Dakota, United States

1160.128.1006 Boehringer Ingelheim Investigational Site, Austin, Texas, United States

1160.128.1104 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1160.128.1061 Boehringer Ingelheim Investigational Site, McKinney, Texas, United States

1160.128.1090 Boehringer Ingelheim Investigational Site, New Braunfels, Texas, United States

1160.128.1082 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States

1160.128.1102 Boehringer Ingelheim Investigational Site, Layton, Utah, United States

1160.128.1077 Boehringer Ingelheim Investigational Site, Danville, Virginia, United States

1160.128.1064 Boehringer Ingelheim Investigational Site, Falls Church, Virginia, United States

1160.128.1110 Boehringer Ingelheim Investigational Site, Manassas, Virginia, United States

1160.128.1099 Boehringer Ingelheim Investigational Site, Norfolk, Virginia, United States

Starting date: December 2011
Last updated: November 17, 2014