Atrial FibrillationPhase 4NCT01493557

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 Phase 4 study testing pantoprazole, Pradaxa (dabigatran etexilate) and Pradaxa, within 30 minutes after a meal in people with Atrial Fibrillation, run by Boehringer Ingelheim at 103 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: pantoprazole, Pradaxa (dabigatran etexilate) and Pradaxa, within 30 minutes after a meal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,067 participants
Where: 103 sitesin 2 countries
Study dates: Dec 2011to Jul 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

103 sites in 2 countries.

Country

City, postcode or hospital

103 sites in 2 countries

United States81 sites

1160.128.1036 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1160.128.1037 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania
1160.128.1022 Boehringer Ingelheim Investigational Site
Asheville, North Carolina
1160.128.1111 Boehringer Ingelheim Investigational Site
Atlantis, Florida
1160.128.1025 Boehringer Ingelheim Investigational Site
Auburn, Maine
1160.128.1006 Boehringer Ingelheim Investigational Site
Austin, Texas
1160.128.1008 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1160.128.1053 Boehringer Ingelheim Investigational Site
Bend, Oregon
1160.128.1100 Boehringer Ingelheim Investigational Site
Biddeford, Maine
1160.128.1046 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1160.128.1032 Boehringer Ingelheim Investigational Site
Brandon, Florida
1160.128.1016 Boehringer Ingelheim Investigational Site
Bridgeport, Connecticut
1160.128.1066 Boehringer Ingelheim Investigational Site
Bridgeport, Connecticut
1160.128.1034 Boehringer Ingelheim Investigational Site
Camp Hill, Pennsylvania
1160.128.1093 Boehringer Ingelheim Investigational Site
Chandler, Arizona
1160.128.1043 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1160.128.1076 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
1160.128.1005 Boehringer Ingelheim Investigational Site
Colorado Spring, Colorado
1160.128.1041 Boehringer Ingelheim Investigational Site
Columbia, Maryland
1160.128.1014 Boehringer Ingelheim Investigational Site
Columbia, Missouri
1160.128.1096 Boehringer Ingelheim Investigational Site
Columbus, Georgia
1160.128.1021 Boehringer Ingelheim Investigational Site
Coral Springs, Florida
1160.128.1077 Boehringer Ingelheim Investigational Site
Danville, Virginia
1160.128.1027 Boehringer Ingelheim Investigational Site
Daytona Beach, Florida
1160.128.1023 Boehringer Ingelheim Investigational Site
Denver, Colorado
1160.128.1039 Boehringer Ingelheim Investigational Site
Elmer, New Jersey
1160.128.1064 Boehringer Ingelheim Investigational Site
Falls Church, Virginia
1160.128.1035 Boehringer Ingelheim Investigational Site
Flemington, New Jersey
1160.128.1091 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio
1160.128.1052 Boehringer Ingelheim Investigational Site
Gastonia, North Carolina
1160.128.1069 Boehringer Ingelheim Investigational Site
Great Falls, Montana
1160.128.1018 Boehringer Ingelheim Investigational Site
Guilford, Connecticut
1160.128.1105 Boehringer Ingelheim Investigational Site
Hammond, Indiana
1160.128.1063 Boehringer Ingelheim Investigational Site
Hawthorne, New York
1160.128.1033 Boehringer Ingelheim Investigational Site
Hillsboro, Oregon
1160.128.1067 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas
1160.128.1104 Boehringer Ingelheim Investigational Site
Houston, Texas
1160.128.1045 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1160.128.1029 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1160.128.1019 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1160.128.1062 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1160.128.1011 Boehringer Ingelheim Investigational Site
Kalispell, Montana
1160.128.1047 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1160.128.1010 Boehringer Ingelheim Investigational Site
Langhorne, Pennsylvania
1160.128.1054 Boehringer Ingelheim Investigational Site
Largo, Florida
1160.128.1102 Boehringer Ingelheim Investigational Site
Layton, Utah
1160.128.1092 Boehringer Ingelheim Investigational Site
Lincoln, Nebraska
1160.128.1110 Boehringer Ingelheim Investigational Site
Manassas, Virginia
1160.128.1061 Boehringer Ingelheim Investigational Site
McKinney, Texas
1160.128.1073 Boehringer Ingelheim Investigational Site
Melrose Park, Illinois
1160.128.1103 Boehringer Ingelheim Investigational Site
Mesa, California
1160.128.1097 Boehringer Ingelheim Investigational Site
Miami, Florida
1160.128.1109 Boehringer Ingelheim Investigational Site
Miami, Florida
1160.128.1078 Boehringer Ingelheim Investigational Site
Mineola, New York
1160.128.1003 Boehringer Ingelheim Investigational Site
Mobile, Alabama
1160.128.1090 Boehringer Ingelheim Investigational Site
New Braunfels, Texas
1160.128.1094 Boehringer Ingelheim Investigational Site
Newport Beach, California
1160.128.1099 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1160.128.1050 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
1160.128.1107 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1160.128.1059 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1160.128.1087 Boehringer Ingelheim Investigational Site
Orlando, Florida
1160.128.1079 Boehringer Ingelheim Investigational Site
Overland Park, Kansas
1160.128.1058 Boehringer Ingelheim Investigational Site
Pensacola, Florida
1160.128.1056 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1160.128.1007 Boehringer Ingelheim Investigational Site
Port Charlotte, Florida
1160.128.1001 Boehringer Ingelheim Investigational Site
Poughkeepsie, New York
1160.128.1040 Boehringer Ingelheim Investigational Site
Rapid City, South Dakota
1160.128.1015 Boehringer Ingelheim Investigational Site
Rochester Hills, Michigan
1160.128.1060 Boehringer Ingelheim Investigational Site
Rockledge, Florida
1160.128.1068 Boehringer Ingelheim Investigational Site
Roswell, Georgia
1160.128.1012 Boehringer Ingelheim Investigational Site
Salisbury, Maryland
1160.128.1082 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1160.128.1042 Boehringer Ingelheim Investigational Site
San Diego, California
1160.128.1075 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1160.128.1071 Boehringer Ingelheim Investigational Site
Statesville, North Carolina
1160.128.1004 Boehringer Ingelheim Investigational Site
Tupelo, Mississippi
1160.128.1065 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1160.128.1085 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1160.128.1057 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
1160.128.1048 Boehringer Ingelheim Investigational Site
Winfield, Illinois

Other trials in United States

Canada22 sites

1160.128.1166 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador
1160.128.1151 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1160.128.1160 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1160.128.1168 Boehringer Ingelheim Investigational Site
Cambridge, Ontario
1160.128.1164 Boehringer Ingelheim Investigational Site
Collingwood, Ontario
1160.128.1167 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1160.128.1173 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1160.128.1159 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.128.1171 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1160.128.1156 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.128.1157 Boehringer Ingelheim Investigational Site
Kitchener, Ontario
1160.128.1155 Boehringer Ingelheim Investigational Site
London, Ontario
1160.128.1170 Boehringer Ingelheim Investigational Site
Peterborough, Ontario
1160.128.1152 Boehringer Ingelheim Investigational Site
Red Deer, Alberta
1160.128.1154 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
1160.128.1165 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1160.128.1169 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1160.128.1172 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1160.128.1153 Boehringer Ingelheim Investigational Site
Spruce Grove, Alberta
1160.128.1161 Boehringer Ingelheim Investigational Site
Stayner, Ontario
1160.128.1162 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1160.128.1158 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

Other trials in Canada

About this study

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)

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.

Conditions: Atrial Fibrillation
Being tested: pantoprazole, Pradaxa (dabigatran etexilate), Pradaxa, within 30 minutes after a meal
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pantoprazoleDrug
40 mg q.a.m, p.o.
Pradaxa (dabigatran etexilate)Drug
150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
Pradaxa, within 30 minutes after a mealDrug
Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal
Pradaxa (dabigatran etexilate)Drug
150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

Study groups in NCT01493557
Study group	Role	What they receive
Pradaxa (dabigaran etexilate)	Other	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. Receives: Drug: Pradaxa (dabigatran etexilate)
Pradaxa and pantoprazole	Active comparator	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 Receives: Drug: pantoprazole; Drug: Pradaxa (dabigatran etexilate)
Pradaxa, 30 minutes after a meal	Active comparator	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 Receives: Drug: Pradaxa, within 30 minutes after a meal

What is being measured

The primary outcome is the main question the study is designed to answer.

The Rate of Complete Effectiveness of Initial GIS Management Strategy
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.
Measured: Week 4

Secondary outcomes (9)

Rate of Partial Effectiveness of Initial GIS Management Strategies
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.
Measured: Week 4
Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies
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.
Measured: Week 4
Rate of Complete Effectiveness of Combined GIS Management Strategies
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.
Measured: Week 8
Rate of Partial Effectiveness of Combined GIS Management Strategies
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.
Measured: Week 8
Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies
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.
Measured: Week 8
Rates of Complete Effectiveness of GIS at Each Visit.
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.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
Rates of Partial Effectiveness of GIS at Each Visit.
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.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
Rates of Complete or Partial Effectiveness of GIS at Each Visit.
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.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom
Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jul 2014

First posted16 Dec 2011 (estimated)
Study startDec 2011
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,067 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01493557
Sponsor's protocol ID: 1160.128
Status last verified: Sep 2015
First submitted: 12 Dec 2011
Last updated: 5 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

O'Dea D, Whetteckey J, Ting N. A Prospective, Randomized, Open-Label Study to Evaluate Two Management Strategies for Gastrointestinal Symptoms in Patients Newly on Treatment with Dabigatran. Cardiol Ther. 2016 Dec;5(2):187-201. doi: 10.1007/s40119-016-0071-5. Epub 2016 Oct 5.
PubMed 27709460

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01493557
Acronym / sponsor ID: 1160.128
Conditions: Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,067 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 16 Dec 2011 (estimated)
Results: Posted 5 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pradaxa (dabigaran etexilate)	Other	Drug: 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	Active comparator	Drug: pantoprazole, Drug: 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
Pradaxa, 30 minutes after a meal	Active comparator	Drug: Pradaxa, within 30 minutes after a mealPatients 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pantoprazole40 mg q.a.m, p.o.	Drug	Pradaxa and pantoprazole
Pradaxa (dabigatran etexilate)150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)	Drug	Pradaxa (dabigaran etexilate)
Pradaxa, within 30 minutes after a mealPatients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal	Drug	Pradaxa, 30 minutes after a meal
Pradaxa (dabigatran etexilate)150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)	Drug	Pradaxa and pantoprazole

Primary outcome

The Rate of Complete Effectiveness of Initial GIS Management Strategy
Time frame: 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.

9 secondary outcomes

Rate of Partial Effectiveness of Initial GIS Management Strategies
Time frame: Week 4
Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies
Time frame: Week 4
Rate of Complete Effectiveness of Combined GIS Management Strategies
Time frame: Week 8
Rate of Partial Effectiveness of Combined GIS Management Strategies
Time frame: Week 8
Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies
Time frame: Week 8
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
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
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
Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom
Time frame: Week 8

Results and safety

Results posted to the registry on 5 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pradaxa, 30 Minutes After a Meal (Randomized)	0	0
Pantoprazole 40 mg (Randomized)	0	0
Pradaxa, Never Randomized	950	816

Primary outcome: The Rate of Complete Effectiveness of Initial GIS Management Strategy

Time frame: Week 4. Number. Unit: percentage of participants

Measure	Pradaxa, 30 Minutes After a Meal (Randomized) n = 59	Pantoprazole 40 mg (Randomized) n = 58
Value	55.9	67.2

Pradaxa, 30 Minutes After a Meal (Randomized) vs Pantoprazole 40 mg (Randomized): Mean Difference (Final Values): 11.31 (95% CI -6.54 to 29.49), p = 0.2554, Fisher Exact

Population analysed: Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 6 days after end of trial, up to 158 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pradaxa, 30 Minutes After a Meal (Randomized)	2 of 59 (3.4%)	37 of 59 (62.7%)	Not reported
Pantoprazole 40 mg (Randomized)	3 of 58 (5.2%)	35 of 58 (60.3%)	Not reported
Pradaxa, Never Randomized	109 of 950 (11.5%)	161 of 950 (16.9%)	Not reported

Limitations and caveats (from the sponsor): The modest sample size,non-specific nature of symptoms,\&reliance on patient self-reporting of their symptoms may contributed some bias to the final result.An open-label design may lead to patient/investigator bias in reporting symptoms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27709460O'Dea D, Whetteckey J, Ting N. A Prospective, Randomized, Open-Label Study to Evaluate Two Management Strategies for Gastrointestinal Symptoms in Patients Newly on Treatment with Dabigatran. Cardiol Ther. 2016 Dec;5(2):187-201. doi: 10.1007/s40119-016-0071-5. Epub 2016 Oct 5.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

103 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Rate of Complete Effectiveness of Initial GIS Management Strategy (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.