NCT01505881

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
9 countries

30 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 11, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

January 5, 2012

Results QC Date

June 6, 2014

Last Update Submit

July 10, 2014

Conditions

ThromboembolismHeart Valve Prosthesis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Any Adverse Event (AE)

    Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.

    From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Secondary Outcomes (3)

  • Percentage of Patients With AEs Leading to Discontinuation of Trial Drug

    From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

  • Percentage of Patients With Serious AEs

    From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

  • Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.

    From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Study Arms (2)

Dabigatran etexilate

EXPERIMENTAL

Patient dose determined by dose allocated in 1160.113 and CrCl levels

Drug: dabigatran etexilate low doseDrug: dabigatran etexilate intermediate doseDrug: dabigatran etexilate high dose

warfarin

ACTIVE COMPARATOR

warfarin doses to maintain INR levels

Drug: warfarin 5mgDrug: warfarin 1mgDrug: warfarin 3mg

Interventions

dabigatran etexilate low doseDRUG

active treatment (low)

Dabigatran etexilate
warfarin 5mgDRUG

comparator warfarin

warfarin
dabigatran etexilate intermediate doseDRUG

active treatment (medium)

Dabigatran etexilate
warfarin 1mgDRUG

comparator warfarin

warfarin
dabigatran etexilate high doseDRUG

active treatment (high)

Dabigatran etexilate
warfarin 3mgDRUG

comparator warfarin

warfarin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed study 1160.113 per protocol
  • Continuing need for anticoagulation

You may not qualify if:

  • uncontrolled hypertension
  • severe renal impairment
  • active liver disease
  • increased risk of bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

1160.138.32003 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.138.32002 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1160.138.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1160.138.11001 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

Location

1160.138.11009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.138.11011 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1160.138.11012 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Location

1160.138.11007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1160.138.42002 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1160.138.42003 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

1160.138.42004 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

1160.138.42001 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.138.45001 Boehringer Ingelheim Investigational Site

Copenhagen, Denmark

Location

1160.138.45002 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1160.138.33004 Boehringer Ingelheim Investigational Site

Bron, France

Location

1160.138.33001 Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.138.33002 Boehringer Ingelheim Investigational Site

Pessac, France

Location

1160.138.33003 Boehringer Ingelheim Investigational Site

Rennes, France

Location

1160.138.49001 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.138.49002 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1160.138.49004 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1160.138.49003 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

1160.138.49010 Boehringer Ingelheim Investigational Site

Witten, Germany

Location

1160.138.31002 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.138.31004 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1160.138.47002 Boehringer Ingelheim Investigational Site

Bergen, Norway

Location

1160.138.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.138.48004 Boehringer Ingelheim Investigational Site

Gdansk, Poland

Location

1160.138.48003 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.138.48001 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 23991661DERIVED

MeSH Terms

Conditions

Thromboembolism

Interventions

DabigatranWarfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Limitations and Caveats

This study was terminated prematurely due to safety concerns arising during conduct of the trial.

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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 9, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 11, 2014

Results First Posted

July 11, 2014

Record last verified: 2014-07

Locations

PL(3)CA(5)BE(3)CZ(4)DE(5)NO(2)FR(4)DK(2)NL(2)