Dabigatran Etexilate in Patients With Mechanical Heart Valves - Full Text View

Purpose

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Condition	Intervention	Phase
Heart Valve Diseases	Drug: warfarin 1mg Drug: dabigatran etexilate intermediate dose Drug: dabigatran etexilate low dose Drug: warfarin 5mg Drug: dabigatran etexilate high dose Drug: warfarin 3mg	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Heart Valve Diseases

Drug Information available for: Warfarin Warfarin sodium Dabigatran Dabigatran etexilate Dabigatran etexilate mesylate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment:	253
Study Start Date:	October 2011
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dabigatran etexilate Patient dose dependent on screening CrCl levels and TT	Drug: dabigatran etexilate intermediate dose active treatment (medium) Drug: dabigatran etexilate low dose active treatment (low) Drug: dabigatran etexilate high dose active treatment (high)
Active Comparator: warfarin warfarin doses to maintain INR levels	Drug: warfarin 1mg comparator warfarin Drug: warfarin 5mg comparator warfarin Drug: warfarin 3mg comparator warfarin

Detailed Description:

Based on an interim analysis from the phase II, 1160.113 and 1160.138 trials which suggested that the investigated dosing regimen did not achieve the desired results in this patient population, it was decided that from this point forward, patients will discontinue study medication and be followed up for a further six months.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients aged 18-75
Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

Prior valve surgery
Uncontrolled hypertension
severe renal impairment
active liver disease
increased risk of bleeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452347

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Locations

Belgium
1160.113.32007 Boehringer Ingelheim Investigational Site
Brussel, Belgium
1160.113.32003 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1160.113.32006 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1160.113.32002 Boehringer Ingelheim Investigational Site
Genk, Belgium
1160.113.32005 Boehringer Ingelheim Investigational Site
Gent, Belgium
1160.113.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1160.113.32004 Boehringer Ingelheim Investigational Site
Liège, Belgium
Canada, Alberta
1160.113.11002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, Manitoba
1160.113.11006 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
1160.113.11001 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
1160.113.11013 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
1160.113.11009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.113.11011 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1160.113.11012 Boehringer Ingelheim Investigational Site
Newmarket, Ontario, Canada
1160.113.11007 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1160.113.11003 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Czech Republic
1160.113.42002 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1160.113.42005 Boehringer Ingelheim Investigational Site
Hradec Kralove, Czech Republic
1160.113.42003 Boehringer Ingelheim Investigational Site
Olomouc, Czech Republic
1160.113.42004 Boehringer Ingelheim Investigational Site
Ostrava, Czech Republic
1160.113.42001 Boehringer Ingelheim Investigational Site
Prague 5, Czech Republic
Denmark
1160.113.45001 Boehringer Ingelheim Investigational Site
Copenhagen, Denmark
1160.113.45002 Boehringer Ingelheim Investigational Site
Odense C, Denmark
France
1160.113.33004 Boehringer Ingelheim Investigational Site
Bron, France
1160.113.33001 Boehringer Ingelheim Investigational Site
Paris cedex 18, France
1160.113.33002 Boehringer Ingelheim Investigational Site
Pessac, France
1160.113.33003 Boehringer Ingelheim Investigational Site
Rennes Cedex 2, France
Germany
1160.113.49001 Boehringer Ingelheim Investigational Site
Dresden, Germany
1160.113.49002 Boehringer Ingelheim Investigational Site
Essen, Germany
1160.113.49008 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1160.113.49004 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1160.113.49003 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1160.113.49010 Boehringer Ingelheim Investigational Site
Witten, Germany
Netherlands
1160.113.31001 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1160.113.31002 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1160.113.31004 Boehringer Ingelheim Investigational Site
Breda, Netherlands
1160.113.31007 Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Norway
1160.113.47002 Boehringer Ingelheim Investigational Site
Bergen, Norway
1160.113.47001 Boehringer Ingelheim Investigational Site
Oslo, Norway
Poland
1160.113.48004 Boehringer Ingelheim Investigational Site
Gdansk, Poland
1160.113.48002 Boehringer Ingelheim Investigational Site
Krakow, Poland
1160.113.48005 Boehringer Ingelheim Investigational Site
Szczecin, Poland
1160.113.48003 Boehringer Ingelheim Investigational Site
Warszawa, Poland
1160.113.48001 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Sweden
1160.113.46004 Sahlgrenska Universitetssjukhuset
Göteborg, Sweden
1160.113.46003 Skånes Universitetssjukhus Lund
Lund, Sweden
1160.113.46005 Boehringer Ingelheim Investigational Site
Umeå, Sweden
1160.113.46001 Akademiska Sjukhuset
Uppsala, Sweden

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01452347 History of Changes
Other Study ID Numbers:	1160.113, 2010-022685-27
Study First Received:	October 11, 2011
Last Updated:	February 4, 2013
Health Authority:	Belgium: Federal Agency for Medicinal and Health Products Canada: Health Canada Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Netherlands: Central Committee Research Involving Human Subjects Norway: Norwegian Medicines Agency Poland: Registration Medicinal Product Medical Device Biocidal Product Sweden: Medical Products Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013