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
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT01493557
- Lead Sponsor
- Boehringer Ingelheim
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1067
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pradaxa and pantoprazole 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 Pradaxa, 30 minutes after a meal Pradaxa, within 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 Pradaxa (dabigaran etexilate) Pradaxa (dabigatran 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. Pradaxa and pantoprazole Pradaxa (dabigatran etexilate) 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
- Primary Outcome Measures
Name Time Method The Rate of Complete Effectiveness of Initial GIS Management Strategy Week 4 The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.
- Secondary Outcome Measures
Name Time Method Rate of Complete Effectiveness of Combined GIS Management Strategies Week 8 The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom Week 8 Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.
Rate of Partial Effectiveness of Initial GIS Management Strategies Week 4 The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.Rates of Partial Effectiveness of GIS at Each Visit. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.
Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies Week 8 The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies Week 4 The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.Rates of Complete Effectiveness of GIS at Each Visit. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.
Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.Rates of Complete or Partial Effectiveness of GIS at Each Visit. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.
Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.Rate of Partial Effectiveness of Combined GIS Management Strategies Week 8 The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.
Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.
Trial Locations
- Locations (103)
1160.128.1011 Boehringer Ingelheim Investigational Site
🇺🇸Kalispell, Montana, United States
1160.128.1041 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, Maryland, United States
1160.128.1068 Boehringer Ingelheim Investigational Site
🇺🇸Roswell, Georgia, United States
1160.128.1015 Boehringer Ingelheim Investigational Site
🇺🇸Rochester Hills, Michigan, United States
1160.128.1060 Boehringer Ingelheim Investigational Site
🇺🇸Rockledge, Florida, United States
1160.128.1096 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
1160.128.1151 Boehringer Ingelheim Investigational Site
🇨🇦Brampton, Ontario, Canada
1160.128.1036 Boehringer Ingelheim Investigational Site
🇺🇸Albuquerque, New Mexico, United States
1160.128.1014 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, Missouri, United States
1160.128.1058 Boehringer Ingelheim Investigational Site
🇺🇸Pensacola, Florida, United States
1160.128.1164 Boehringer Ingelheim Investigational Site
🇨🇦Collingwood, Ontario, Canada
1160.128.1007 Boehringer Ingelheim Investigational Site
🇺🇸Port Charlotte, Florida, United States
1160.128.1048 Boehringer Ingelheim Investigational Site
🇺🇸Winfield, Illinois, United States
1160.128.1001 Boehringer Ingelheim Investigational Site
🇺🇸Poughkeepsie, New York, United States
1160.128.1169 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1160.128.1022 Boehringer Ingelheim Investigational Site
🇺🇸Asheville, North Carolina, United States
1160.128.1071 Boehringer Ingelheim Investigational Site
🇺🇸Statesville, North Carolina, United States
1160.128.1056 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
1160.128.1012 Boehringer Ingelheim Investigational Site
🇺🇸Salisbury, Maryland, United States
1160.128.1155 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1160.128.1075 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
1160.128.1073 Boehringer Ingelheim Investigational Site
🇺🇸Melrose Park, Illinois, United States
1160.128.1105 Boehringer Ingelheim Investigational Site
🇺🇸Hammond, Indiana, United States
1160.128.1170 Boehringer Ingelheim Investigational Site
🇨🇦Peterborough, Ontario, Canada
1160.128.1052 Boehringer Ingelheim Investigational Site
🇺🇸Gastonia, North Carolina, United States
1160.128.1158 Boehringer Ingelheim Investigational Site
🇨🇦Victoria, British Columbia, Canada
1160.128.1078 Boehringer Ingelheim Investigational Site
🇺🇸Mineola, New York, United States
1160.128.1161 Boehringer Ingelheim Investigational Site
🇨🇦Stayner, Ontario, Canada
1160.128.1091 Boehringer Ingelheim Investigational Site
🇺🇸Gallipolis, Ohio, United States
1160.128.1037 Boehringer Ingelheim Investigational Site
🇺🇸Altoona, Pennsylvania, United States
1160.128.1171 Boehringer Ingelheim Investigational Site
🇨🇦Sudbury, Ontario, Canada
1160.128.1162 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1160.128.1029 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
1160.128.1045 Boehringer Ingelheim Investigational Site
🇺🇸Huntsville, Alabama, United States
1160.128.1003 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
1160.128.1093 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
1160.128.1005 Boehringer Ingelheim Investigational Site
🇺🇸Colorado Spring, Colorado, United States
1160.128.1066 Boehringer Ingelheim Investigational Site
🇺🇸Bridgeport, Connecticut, United States
1160.128.1018 Boehringer Ingelheim Investigational Site
🇺🇸Guilford, Connecticut, United States
1160.128.1016 Boehringer Ingelheim Investigational Site
🇺🇸Bridgeport, 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
1160.128.1111 Boehringer Ingelheim Investigational Site
🇺🇸Atlantis, Florida, United States
1160.128.1085 Boehringer Ingelheim Investigational Site
🇺🇸Washington, District of Columbia, United States
1160.128.1021 Boehringer Ingelheim Investigational Site
🇺🇸Coral Springs, Florida, United States
1160.128.1032 Boehringer Ingelheim Investigational Site
🇺🇸Brandon, Florida, United States
1160.128.1019 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
1160.128.1027 Boehringer Ingelheim Investigational Site
🇺🇸Daytona Beach, 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
1160.128.1079 Boehringer Ingelheim Investigational Site
🇺🇸Overland Park, Kansas, United States
1160.128.1046 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1160.128.1042 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1160.128.1023 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
1160.128.1107 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
1160.128.1063 Boehringer Ingelheim Investigational Site
🇺🇸Hawthorne, New York, 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
1160.128.1065 Boehringer Ingelheim Investigational Site
🇺🇸Uniontown, Pennsylvania, United States
1160.128.1006 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1160.128.1104 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1160.128.1099 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
1160.128.1082 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1160.128.1090 Boehringer Ingelheim Investigational Site
🇺🇸New Braunfels, Texas, United States
1160.128.1077 Boehringer Ingelheim Investigational Site
🇺🇸Danville, Virginia, United States
1160.128.1061 Boehringer Ingelheim Investigational Site
🇺🇸McKinney, Texas, United States
1160.128.1166 Boehringer Ingelheim Investigational Site
🇨🇦Bay Roberts, Newfoundland and Labrador, Canada
1160.128.1069 Boehringer Ingelheim Investigational Site
🇺🇸Great Falls, Montana, United States
1160.128.1008 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1160.128.1092 Boehringer Ingelheim Investigational Site
🇺🇸Lincoln, Nebraska, United States
1160.128.1100 Boehringer Ingelheim Investigational Site
🇺🇸Biddeford, Maine, United States
1160.128.1035 Boehringer Ingelheim Investigational Site
🇺🇸Flemington, New Jersey, United States
1160.128.1152 Boehringer Ingelheim Investigational Site
🇨🇦Red Deer, Alberta, Canada
1160.128.1004 Boehringer Ingelheim Investigational Site
🇺🇸Tupelo, Mississippi, United States
1160.128.1076 Boehringer Ingelheim Investigational Site
🇺🇸Coeur d' Alene, Idaho, United States
1160.128.1040 Boehringer Ingelheim Investigational Site
🇺🇸Rapid City, South Dakota, United States
1160.128.1159 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1160.128.1039 Boehringer Ingelheim Investigational Site
🇺🇸Elmer, New Jersey, United States
1160.128.1160 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1160.128.1025 Boehringer Ingelheim Investigational Site
🇺🇸Auburn, Maine, United States
1160.128.1033 Boehringer Ingelheim Investigational Site
🇺🇸Hillsboro, Oregon, United States
1160.128.1167 Boehringer Ingelheim Investigational Site
🇨🇦Coquitlam, British Columbia, Canada
1160.128.1154 Boehringer Ingelheim Investigational Site
🇨🇦Saint John, New Brunswick, Canada
1160.128.1053 Boehringer Ingelheim Investigational Site
🇺🇸Bend, Oregon, United States
1160.128.1102 Boehringer Ingelheim Investigational Site
🇺🇸Layton, Utah, United States
1160.128.1172 Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
1160.128.1087 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1160.128.1059 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
1160.128.1043 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
1160.128.1047 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Missouri, 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
1160.128.1153 Boehringer Ingelheim Investigational Site
🇨🇦Spruce Grove, Alberta, Canada
1160.128.1168 Boehringer Ingelheim Investigational Site
🇨🇦Cambridge, 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
1160.128.1165 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada