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

NCT01493557 | Completed Phase 4 Results

• 1 other identifier: 1160.128
• Study Type: interventional
• Target: 1,067
• Locations: 2 countries
• Sites: 103

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (9)

• Rate of Partial Effectiveness of Initial GIS Management Strategies

  Week 4

• Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies

  Week 4

• Rate of Complete Effectiveness of Combined GIS Management Strategies

  Week 8

• Rate of Partial Effectiveness of Combined GIS Management Strategies

  Week 8

• Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies

  Week 8

Study Arms (3)

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.

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

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

Drug: Pradaxa, within 30 minutes after a meal

Interventions

pantoprazole DRUG

40 mg q.a.m, p.o.

Pradaxa and pantoprazole

Pradaxa (dabigatran etexilate) DRUG

150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

Pradaxa (dabigaran etexilate)

Pradaxa, within 30 minutes after a meal DRUG

Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal

Pradaxa, 30 minutes after a meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (103)

1160.128.1046 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1160.128.1045 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1160.128.1003 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1160.128.1093 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

Location

1160.128.1067 Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

Location

1160.128.1103 Boehringer Ingelheim Investigational Site

Mesa, California, United States

Location

1160.128.1094 Boehringer Ingelheim Investigational Site

Newport Beach, California, United States

Location

1160.128.1042 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1160.128.1005 Boehringer Ingelheim Investigational Site

Colorado Spring, Colorado, United States

Location

1160.128.1023 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1160.128.1016 Boehringer Ingelheim Investigational Site

Bridgeport, Connecticut, United States

Location

1160.128.1066 Boehringer Ingelheim Investigational Site

Bridgeport, Connecticut, United States

Location

1160.128.1018 Boehringer Ingelheim Investigational Site

Guilford, Connecticut, United States

Location

1160.128.1050 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Location

1160.128.1057 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

1160.128.1085 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1160.128.1111 Boehringer Ingelheim Investigational Site

Atlantis, Florida, United States

Location

1160.128.1032 Boehringer Ingelheim Investigational Site

Brandon, Florida, United States

Location

1160.128.1021 Boehringer Ingelheim Investigational Site

Coral Springs, Florida, United States

Location

1160.128.1027 Boehringer Ingelheim Investigational Site

Daytona Beach, Florida, United States

Location

1160.128.1019 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1160.128.1062 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1160.128.1054 Boehringer Ingelheim Investigational Site

Largo, Florida, United States

Location

1160.128.1097 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1160.128.1109 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1160.128.1087 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1160.128.1058 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Location

1160.128.1007 Boehringer Ingelheim Investigational Site

Port Charlotte, Florida, United States

Location

1160.128.1060 Boehringer Ingelheim Investigational Site

Rockledge, Florida, United States

Location

1160.128.1096 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

1160.128.1068 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

1160.128.1076 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1160.128.1073 Boehringer Ingelheim Investigational Site

Melrose Park, Illinois, United States

Location

1160.128.1048 Boehringer Ingelheim Investigational Site

Winfield, Illinois, United States

Location

1160.128.1105 Boehringer Ingelheim Investigational Site

Hammond, Indiana, United States

Location

1160.128.1029 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1160.128.1079 Boehringer Ingelheim Investigational Site

Overland Park, Kansas, United States

Location

1160.128.1008 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

1160.128.1025 Boehringer Ingelheim Investigational Site

Auburn, Maine, United States

Location

1160.128.1100 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

Location

1160.128.1041 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

Location

1160.128.1012 Boehringer Ingelheim Investigational Site

Salisbury, Maryland, United States

Location

1160.128.1015 Boehringer Ingelheim Investigational Site

Rochester Hills, Michigan, United States

Location

1160.128.1004 Boehringer Ingelheim Investigational Site

Tupelo, Mississippi, United States

Location

1160.128.1014 Boehringer Ingelheim Investigational Site

Columbia, Missouri, United States

Location

1160.128.1047 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1160.128.1075 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1160.128.1069 Boehringer Ingelheim Investigational Site

Great Falls, Montana, United States

Location

1160.128.1011 Boehringer Ingelheim Investigational Site

Kalispell, Montana, United States

Location

1160.128.1092 Boehringer Ingelheim Investigational Site

Lincoln, Nebraska, United States

Location

1160.128.1059 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1160.128.1039 Boehringer Ingelheim Investigational Site

Elmer, New Jersey, United States

Location

1160.128.1035 Boehringer Ingelheim Investigational Site

Flemington, New Jersey, United States

Location

1160.128.1036 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1160.128.1063 Boehringer Ingelheim Investigational Site

Hawthorne, New York, United States

Location

1160.128.1078 Boehringer Ingelheim Investigational Site

Mineola, New York, United States

Location

1160.128.1001 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Location

1160.128.1022 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

Location

1160.128.1052 Boehringer Ingelheim Investigational Site

Gastonia, North Carolina, United States

Location

1160.128.1071 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Location

1160.128.1091 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

Location

1160.128.1107 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1160.128.1053 Boehringer Ingelheim Investigational Site

Bend, Oregon, United States

Location

1160.128.1033 Boehringer Ingelheim Investigational Site

Hillsboro, Oregon, United States

Location

1160.128.1037 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Location

1160.128.1034 Boehringer Ingelheim Investigational Site

Camp Hill, Pennsylvania, United States

Location

1160.128.1010 Boehringer Ingelheim Investigational Site

Langhorne, Pennsylvania, United States

Location

1160.128.1056 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1160.128.1065 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1160.128.1043 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1160.128.1040 Boehringer Ingelheim Investigational Site

Rapid City, South Dakota, United States

Location

1160.128.1006 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1160.128.1104 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1160.128.1061 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

Location

1160.128.1090 Boehringer Ingelheim Investigational Site

New Braunfels, Texas, United States

Location

1160.128.1082 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1160.128.1102 Boehringer Ingelheim Investigational Site

Layton, Utah, United States

Location

1160.128.1077 Boehringer Ingelheim Investigational Site

Danville, Virginia, United States

Location

1160.128.1064 Boehringer Ingelheim Investigational Site

Falls Church, Virginia, United States

Location

1160.128.1110 Boehringer Ingelheim Investigational Site

Manassas, Virginia, United States

Location

1160.128.1099 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

1160.128.1160 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1160.128.1159 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.128.1152 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Location

1160.128.1153 Boehringer Ingelheim Investigational Site

Spruce Grove, Alberta, Canada

Location

1160.128.1167 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Location

1160.128.1158 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1160.128.1154 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

Location

1160.128.1166 Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

Location

1160.128.1151 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Location

1160.128.1168 Boehringer Ingelheim Investigational Site

Cambridge, Ontario, Canada

Location

1160.128.1164 Boehringer Ingelheim Investigational Site

Collingwood, Ontario, Canada

Location

1160.128.1173 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Location

1160.128.1171 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Location

1160.128.1156 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.128.1157 Boehringer Ingelheim Investigational Site

Kitchener, Ontario, Canada

Location

1160.128.1155 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1160.128.1170 Boehringer Ingelheim Investigational Site

Peterborough, Ontario, Canada

Location

1160.128.1165 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1160.128.1169 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1160.128.1161 Boehringer Ingelheim Investigational Site

Stayner, Ontario, Canada

Location

1160.128.1162 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1160.128.1172 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 27709460 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Pantoprazole; Dabigatran; Postprandial Period

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Limitations and Caveats

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.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 5, 2015
• Results First Posted: October 5, 2015

Record last verified: 2015-09

Locations

US (81); CA (22)