Clinical trial NCT01505881: Follow on Study From RE-ALIGN
Official title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thromboembolism
Heart Valve Prosthesis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-01-09
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.


Eligibility criteria: Inclusion criteria:

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Exclusion criteria:

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding

Primary outcomes:
measure: Percentage of Patients With Any Adverse Event (AE)
timeFrame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Secondary outcomes:
measure: Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
timeFrame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
measure: Percentage of Patients With Serious AEs
timeFrame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
measure: Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
timeFrame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: 1160.138.32003 Boehringer Ingelheim Investigational Site
city: Genk
country: Belgium
facility: 1160.138.32002 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1160.138.32001 Boehringer Ingelheim Investigational Site
city: Saint John
country: Canada
facility: 1160.138.11001 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Hamilton
country: Canada
facility: 1160.138.11009 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1160.138.11011 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1160.138.11012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1160.138.11007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Brno
country: Czech Republic
facility: 1160.138.42002 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 1160.138.42003 Boehringer Ingelheim Investigational Site
city: Ostrava
country: Czech Republic
facility: 1160.138.42004 Boehringer Ingelheim Investigational Site
city: Prague 5
country: Czech Republic
facility: 1160.138.42001 Boehringer Ingelheim Investigational Site
city: Copenhagen
country: Denmark
facility: 1160.138.45001 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1160.138.45002 Boehringer Ingelheim Investigational Site
city: Bron
country: France
facility: 1160.138.33004 Boehringer Ingelheim Investigational Site
city: Paris cedex 18
country: France
facility: 1160.138.33001 Boehringer Ingelheim Investigational Site
city: Pessac
country: France
facility: 1160.138.33002 Boehringer Ingelheim Investigational Site
city: Rennes Cedex 2
country: France
facility: 1160.138.33003 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1160.138.49001 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1160.138.49002 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1160.138.49004 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 1160.138.49003 Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: 1160.138.49010 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.138.31002 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1160.138.31004 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1160.138.47002 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.138.47001 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1160.138.48004 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1160.138.48003 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1160.138.48001 Boehringer Ingelheim Investigational Site
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.