Clinical trial NCT01452347: Dabigatran Etexilate in Patients With Mechanical Heart Valves
Official title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Valve Diseases
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding

Primary outcomes:
measure: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
timeFrame: Week 1
measure: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
timeFrame: Week 2
measure: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
timeFrame: Week 4
measure: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
timeFrame: Week 1
measure: Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
timeFrame: Week 2
measure: Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4
timeFrame: Week 4
measure: Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: 1160.113.32007 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1160.113.32003 Boehringer Ingelheim Investigational Site
city: Genk
country: Belgium
facility: 1160.113.32002 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1160.113.32005 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1160.113.32001 Boehringer Ingelheim Investigational Site
city: Edmonton
country: Canada
facility: 1160.113.11002 Boehringer Ingelheim Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: 1160.113.11006 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Saint John
country: Canada
facility: 1160.113.11001 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Hamilton
country: Canada
facility: 1160.113.11009 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1160.113.11011 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1160.113.11012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1160.113.11007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Brno
country: Czech Republic
facility: 1160.113.42002 Boehringer Ingelheim Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: 1160.113.42005 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 1160.113.42003 Boehringer Ingelheim Investigational Site
city: Ostrava
country: Czech Republic
facility: 1160.113.42004 Boehringer Ingelheim Investigational Site
city: Prague 5
country: Czech Republic
facility: 1160.113.42001 Boehringer Ingelheim Investigational Site
city: Copenhagen
country: Denmark
facility: 1160.113.45001 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1160.113.45002 Boehringer Ingelheim Investigational Site
city: Bron
country: France
facility: 1160.113.33004 Boehringer Ingelheim Investigational Site
city: Paris cedex 18
country: France
facility: 1160.113.33001 Boehringer Ingelheim Investigational Site
city: Pessac
country: France
facility: 1160.113.33002 Boehringer Ingelheim Investigational Site
city: Rennes Cedex 2
country: France
facility: 1160.113.33003 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1160.113.49001 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1160.113.49002 Boehringer Ingelheim Investigational Site
city: Frankfurt am Main
country: Germany
facility: 1160.113.49008 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1160.113.49004 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 1160.113.49003 Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: 1160.113.49010 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.113.31001 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.113.31002 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1160.113.31004 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1160.113.47002 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.113.47001 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1160.113.48004 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1160.113.48003 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1160.113.48001 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.113.46004 Sahlgrenska Universitetssjukhuset
city: Lund
country: Sweden
facility: 1160.113.46003 Skånes Universitetssjukhus Lund
city: Uppsala
country: Sweden
facility: 1160.113.46001 Akademiska Sjukhuset
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.