- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493557
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada
- 1160.128.1160 Boehringer Ingelheim Investigational Site
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Edmonton, Alberta, Canada
- 1160.128.1159 Boehringer Ingelheim Investigational Site
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Red Deer, Alberta, Canada
- 1160.128.1152 Boehringer Ingelheim Investigational Site
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Spruce Grove, Alberta, Canada
- 1160.128.1153 Boehringer Ingelheim Investigational Site
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British Columbia
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Coquitlam, British Columbia, Canada
- 1160.128.1167 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Canada
- 1160.128.1158 Boehringer Ingelheim Investigational Site
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New Brunswick
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Saint John, New Brunswick, Canada
- 1160.128.1154 Boehringer Ingelheim Investigational Site
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Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada
- 1160.128.1166 Boehringer Ingelheim Investigational Site
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Ontario
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Brampton, Ontario, Canada
- 1160.128.1151 Boehringer Ingelheim Investigational Site
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Cambridge, Ontario, Canada
- 1160.128.1168 Boehringer Ingelheim Investigational Site
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Collingwood, Ontario, Canada
- 1160.128.1164 Boehringer Ingelheim Investigational Site
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Corunna, Ontario, Canada
- 1160.128.1173 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
- 1160.128.1156 Boehringer Ingelheim Investigational Site
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Kitchener, Ontario, Canada
- 1160.128.1157 Boehringer Ingelheim Investigational Site
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London, Ontario, Canada
- 1160.128.1155 Boehringer Ingelheim Investigational Site
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Peterborough, Ontario, Canada
- 1160.128.1170 Boehringer Ingelheim Investigational Site
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Sarnia, Ontario, Canada
- 1160.128.1165 Boehringer Ingelheim Investigational Site
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Sarnia, Ontario, Canada
- 1160.128.1169 Boehringer Ingelheim Investigational Site
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Stayner, Ontario, Canada
- 1160.128.1161 Boehringer Ingelheim Investigational Site
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Sudbury, Ontario, Canada
- 1160.128.1171 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
- 1160.128.1162 Boehringer Ingelheim Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- 1160.128.1172 Boehringer Ingelheim Investigational Site
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Alabama
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Birmingham, Alabama, United States
- 1160.128.1046 Boehringer Ingelheim Investigational Site
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Huntsville, Alabama, United States
- 1160.128.1045 Boehringer Ingelheim Investigational Site
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Mobile, Alabama, United States
- 1160.128.1003 Boehringer Ingelheim Investigational Site
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Arizona
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Chandler, Arizona, United States
- 1160.128.1093 Boehringer Ingelheim Investigational Site
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Arkansas
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Hot Springs, Arkansas, United States
- 1160.128.1067 Boehringer Ingelheim Investigational Site
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California
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Mesa, California, United States
- 1160.128.1103 Boehringer Ingelheim Investigational Site
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Newport Beach, California, United States
- 1160.128.1094 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
- 1160.128.1042 Boehringer Ingelheim Investigational Site
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Colorado
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Colorado Spring, Colorado, United States
- 1160.128.1005 Boehringer Ingelheim Investigational Site
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Denver, Colorado, United States
- 1160.128.1023 Boehringer Ingelheim Investigational Site
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Connecticut
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Bridgeport, Connecticut, United States
- 1160.128.1016 Boehringer Ingelheim Investigational Site
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Bridgeport, Connecticut, United States
- 1160.128.1066 Boehringer Ingelheim Investigational Site
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Guilford, Connecticut, United States
- 1160.128.1018 Boehringer Ingelheim Investigational Site
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Norwalk, Connecticut, United States
- 1160.128.1050 Boehringer Ingelheim Investigational Site
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Waterbury, Connecticut, United States
- 1160.128.1057 Boehringer Ingelheim Investigational Site
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District of Columbia
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Washington, District of Columbia, United States
- 1160.128.1085 Boehringer Ingelheim Investigational Site
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Florida
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Atlantis, Florida, United States
- 1160.128.1111 Boehringer Ingelheim Investigational Site
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Brandon, Florida, United States
- 1160.128.1032 Boehringer Ingelheim Investigational Site
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Coral Springs, Florida, United States
- 1160.128.1021 Boehringer Ingelheim Investigational Site
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Daytona Beach, Florida, United States
- 1160.128.1027 Boehringer Ingelheim Investigational Site
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Jacksonville, Florida, United States
- 1160.128.1019 Boehringer Ingelheim Investigational Site
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Jacksonville, Florida, United States
- 1160.128.1062 Boehringer Ingelheim Investigational Site
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Largo, Florida, United States
- 1160.128.1054 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1160.128.1097 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1160.128.1109 Boehringer Ingelheim Investigational Site
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Orlando, Florida, United States
- 1160.128.1087 Boehringer Ingelheim Investigational Site
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Pensacola, Florida, United States
- 1160.128.1058 Boehringer Ingelheim Investigational Site
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Port Charlotte, Florida, United States
- 1160.128.1007 Boehringer Ingelheim Investigational Site
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Rockledge, Florida, United States
- 1160.128.1060 Boehringer Ingelheim Investigational Site
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Georgia
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Columbus, Georgia, United States
- 1160.128.1096 Boehringer Ingelheim Investigational Site
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Roswell, Georgia, United States
- 1160.128.1068 Boehringer Ingelheim Investigational Site
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Idaho
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Coeur d' Alene, Idaho, United States
- 1160.128.1076 Boehringer Ingelheim Investigational Site
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Illinois
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Melrose Park, Illinois, United States
- 1160.128.1073 Boehringer Ingelheim Investigational Site
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Winfield, Illinois, United States
- 1160.128.1048 Boehringer Ingelheim Investigational Site
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Indiana
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Hammond, Indiana, United States
- 1160.128.1105 Boehringer Ingelheim Investigational Site
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Indianapolis, Indiana, United States
- 1160.128.1029 Boehringer Ingelheim Investigational Site
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Kansas
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Overland Park, Kansas, United States
- 1160.128.1079 Boehringer Ingelheim Investigational Site
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Louisiana
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Baton Rouge, Louisiana, United States
- 1160.128.1008 Boehringer Ingelheim Investigational Site
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Maine
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Auburn, Maine, United States
- 1160.128.1025 Boehringer Ingelheim Investigational Site
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Biddeford, Maine, United States
- 1160.128.1100 Boehringer Ingelheim Investigational Site
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Maryland
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Columbia, Maryland, United States
- 1160.128.1041 Boehringer Ingelheim Investigational Site
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Salisbury, Maryland, United States
- 1160.128.1012 Boehringer Ingelheim Investigational Site
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Michigan
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Rochester Hills, Michigan, United States
- 1160.128.1015 Boehringer Ingelheim Investigational Site
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Mississippi
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Tupelo, Mississippi, United States
- 1160.128.1004 Boehringer Ingelheim Investigational Site
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Missouri
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Columbia, Missouri, United States
- 1160.128.1014 Boehringer Ingelheim Investigational Site
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Kansas City, Missouri, United States
- 1160.128.1047 Boehringer Ingelheim Investigational Site
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St. Louis, Missouri, United States
- 1160.128.1075 Boehringer Ingelheim Investigational Site
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Montana
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Great Falls, Montana, United States
- 1160.128.1069 Boehringer Ingelheim Investigational Site
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Kalispell, Montana, United States
- 1160.128.1011 Boehringer Ingelheim Investigational Site
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Nebraska
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Lincoln, Nebraska, United States
- 1160.128.1092 Boehringer Ingelheim Investigational Site
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Omaha, Nebraska, United States
- 1160.128.1059 Boehringer Ingelheim Investigational Site
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New Jersey
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Elmer, New Jersey, United States
- 1160.128.1039 Boehringer Ingelheim Investigational Site
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Flemington, New Jersey, United States
- 1160.128.1035 Boehringer Ingelheim Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States
- 1160.128.1036 Boehringer Ingelheim Investigational Site
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New York
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Hawthorne, New York, United States
- 1160.128.1063 Boehringer Ingelheim Investigational Site
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Mineola, New York, United States
- 1160.128.1078 Boehringer Ingelheim Investigational Site
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Poughkeepsie, New York, United States
- 1160.128.1001 Boehringer Ingelheim Investigational Site
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North Carolina
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Asheville, North Carolina, United States
- 1160.128.1022 Boehringer Ingelheim Investigational Site
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Gastonia, North Carolina, United States
- 1160.128.1052 Boehringer Ingelheim Investigational Site
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Statesville, North Carolina, United States
- 1160.128.1071 Boehringer Ingelheim Investigational Site
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Ohio
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Gallipolis, Ohio, United States
- 1160.128.1091 Boehringer Ingelheim Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- 1160.128.1107 Boehringer Ingelheim Investigational Site
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Oregon
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Bend, Oregon, United States
- 1160.128.1053 Boehringer Ingelheim Investigational Site
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Hillsboro, Oregon, United States
- 1160.128.1033 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States
- 1160.128.1037 Boehringer Ingelheim Investigational Site
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Camp Hill, Pennsylvania, United States
- 1160.128.1034 Boehringer Ingelheim Investigational Site
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Langhorne, Pennsylvania, United States
- 1160.128.1010 Boehringer Ingelheim Investigational Site
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Pittsburgh, Pennsylvania, United States
- 1160.128.1056 Boehringer Ingelheim Investigational Site
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Uniontown, Pennsylvania, United States
- 1160.128.1065 Boehringer Ingelheim Investigational Site
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South Carolina
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Charleston, South Carolina, United States
- 1160.128.1043 Boehringer Ingelheim Investigational Site
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South Dakota
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Rapid City, South Dakota, United States
- 1160.128.1040 Boehringer Ingelheim Investigational Site
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Texas
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Austin, Texas, United States
- 1160.128.1006 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1160.128.1104 Boehringer Ingelheim Investigational Site
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McKinney, Texas, United States
- 1160.128.1061 Boehringer Ingelheim Investigational Site
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New Braunfels, Texas, United States
- 1160.128.1090 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
- 1160.128.1082 Boehringer Ingelheim Investigational Site
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Utah
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Layton, Utah, United States
- 1160.128.1102 Boehringer Ingelheim Investigational Site
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Virginia
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Danville, Virginia, United States
- 1160.128.1077 Boehringer Ingelheim Investigational Site
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Falls Church, Virginia, United States
- 1160.128.1064 Boehringer Ingelheim Investigational Site
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Manassas, Virginia, United States
- 1160.128.1110 Boehringer Ingelheim Investigational Site
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Norfolk, Virginia, United States
- 1160.128.1099 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 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.
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150 mg or 75 mg b.i.d.
(150 mg or 110 mg b.i.d. in Canada)
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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
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150 mg or 75 mg b.i.d.
(150 mg or 110 mg b.i.d. in Canada)
40 mg q.a.m, p.o.
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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
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Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Rate of Complete Effectiveness of Initial GIS Management Strategy
Time Frame: Week 4
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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. |
Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Partial Effectiveness of Initial GIS Management Strategies
Time Frame: Week 4
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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. |
Week 4
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Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies
Time Frame: Week 4
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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. |
Week 4
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Rate of Complete Effectiveness of Combined GIS Management Strategies
Time Frame: Week 8
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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. |
Week 8
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Rate of Partial Effectiveness of Combined GIS Management Strategies
Time Frame: 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. |
Week 8
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Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies
Time Frame: Week 8
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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. |
Week 8
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Rates of Complete Effectiveness of GIS at Each Visit.
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
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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. |
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
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Rates of Partial Effectiveness of GIS at Each Visit.
Time Frame: 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. |
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
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Rates of Complete or Partial Effectiveness of GIS at Each Visit.
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
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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. |
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
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Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom
Time Frame: Week 8
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Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.
|
Week 8
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Arrhythmias, Cardiac
- Embolism
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Protease Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dabigatran
- Pantoprazole
Other Study ID Numbers
- 1160.128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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