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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01493557
First received: December 12, 2011
Last updated: August 20, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Atrial Fibrillation
Drug: pantoprazole
Drug: Pradaxa (dabigatran etexilate)
Drug: Pradaxa, within 30 minutes after a meal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Bleeding and other adverse events reported by patients and/or observed by Investigators [ Time Frame: Up to 5.5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of patients experiencing complete, partial, or complete or partial effectiveness on gastrointestinal symptoms (GIS) at each week (other than week 4). [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Time between symptom onset and first observed complete or partial effectiveness [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Time between symptom onset and last observed symptom [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 1067
Study Start Date: December 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Pradaxa (dabigatran etexilate)
150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
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
Drug: pantoprazole
40 mg q.a.m, p.o.
Drug: Pradaxa (dabigatran etexilate)
150 mg or 75 mg b.i.d.
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493557

  Hide Study Locations
Locations
United States, Alabama
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
United States, Arizona
1160.128.1093 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
United States, Arkansas
1160.128.1067 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
United States, California
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
United States, Colorado
1160.128.1005 Boehringer Ingelheim Investigational Site
Colorado Spring, Colorado, United States
1160.128.1023 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Connecticut
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
United States, District of Columbia
1160.128.1085 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
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
1160.128.1062 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1160.128.1019 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1160.128.1054 Boehringer Ingelheim Investigational Site
Largo, Florida, United States
1160.128.1109 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1160.128.1097 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
United States, Georgia
1160.128.1096 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
1160.128.1068 Boehringer Ingelheim Investigational Site
Roswell, Georgia, United States
United States, Idaho
1160.128.1076 Boehringer Ingelheim Investigational Site
Coeur d' Alene, Idaho, United States
United States, Illinois
1160.128.1073 Boehringer Ingelheim Investigational Site
Melrose Park, Illinois, United States
1160.128.1048 Boehringer Ingelheim Investigational Site
Winfield, Illinois, United States
United States, Indiana
1160.128.1105 Boehringer Ingelheim Investigational Site
Hammond, Indiana, United States
1160.128.1029 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
United States, Kansas
1160.128.1079 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
United States, Louisiana
1160.128.1008 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
United States, Maine
1160.128.1025 Boehringer Ingelheim Investigational Site
Auburn, Maine, United States
1160.128.1100 Boehringer Ingelheim Investigational Site
Biddeford, Maine, United States
United States, Maryland
1160.128.1041 Boehringer Ingelheim Investigational Site
Columbia, Maryland, United States
1160.128.1012 Boehringer Ingelheim Investigational Site
Salisbury, Maryland, United States
United States, Michigan
1160.128.1015 Boehringer Ingelheim Investigational Site
Rochester Hills, Michigan, United States
United States, Mississippi
1160.128.1004 Boehringer Ingelheim Investigational Site
Tupelo, Mississippi, United States
United States, Missouri
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
United States, Montana
1160.128.1069 Boehringer Ingelheim Investigational Site
Great Falls, Montana, United States
1160.128.1011 Boehringer Ingelheim Investigational Site
Kalispell, Montana, United States
United States, Nebraska
1160.128.1092 Boehringer Ingelheim Investigational Site
Lincoln, Nebraska, United States
1160.128.1059 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, New Jersey
1160.128.1039 Boehringer Ingelheim Investigational Site
Elmer, New Jersey, United States
1160.128.1035 Boehringer Ingelheim Investigational Site
Flemington, New Jersey, United States
United States, New Mexico
1160.128.1036 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
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
United States, North Carolina
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
United States, Ohio
1160.128.1091 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio, United States
United States, Oklahoma
1160.128.1107 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Oregon
1160.128.1053 Boehringer Ingelheim Investigational Site
Bend, Oregon, United States
1160.128.1033 Boehringer Ingelheim Investigational Site
Hillsboro, Oregon, United States
United States, Pennsylvania
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
United States, South Carolina
1160.128.1043 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, South Dakota
1160.128.1040 Boehringer Ingelheim Investigational Site
Rapid City, South Dakota, United States
United States, Texas
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
United States, Utah
1160.128.1102 Boehringer Ingelheim Investigational Site
Layton, Utah, United States
United States, Virginia
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
Canada, Alberta
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
Canada, British Columbia
1160.128.1167 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia, Canada
1160.128.1158 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, New Brunswick
1160.128.1154 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
1160.128.1166 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada
Canada, Ontario
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
1160.128.1169 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
1160.128.1165 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
Canada, Saskatchewan
1160.128.1172 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01493557     History of Changes
Other Study ID Numbers: 1160.128
Study First Received: December 12, 2011
Last Updated: August 20, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Dabigatran
Pantoprazole
Anti-Ulcer Agents
Anticoagulants
Antithrombins
Enzyme Inhibitors
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Proton Pump Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014