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Follow on Study From RE-ALIGN

NCT ID: NCT01505881

Last Updated: 2014-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Thromboembolism Heart Valve Prosthesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dabigatran etexilate

Patient dose determined by dose allocated in 1160.113 and CrCl levels

Group Type EXPERIMENTAL

dabigatran etexilate low dose

Intervention Type DRUG

active treatment (low)

dabigatran etexilate intermediate dose

Intervention Type DRUG

active treatment (medium)

dabigatran etexilate high dose

Intervention Type DRUG

active treatment (high)

warfarin

warfarin doses to maintain INR levels

Group Type ACTIVE_COMPARATOR

warfarin 5mg

Intervention Type DRUG

comparator warfarin

warfarin 1mg

Intervention Type DRUG

comparator warfarin

warfarin 3mg

Intervention Type DRUG

comparator warfarin

Interventions

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dabigatran etexilate low dose

active treatment (low)

Intervention Type DRUG

warfarin 5mg

comparator warfarin

Intervention Type DRUG

dabigatran etexilate intermediate dose

active treatment (medium)

Intervention Type DRUG

warfarin 1mg

comparator warfarin

Intervention Type DRUG

dabigatran etexilate high dose

active treatment (high)

Intervention Type DRUG

warfarin 3mg

comparator warfarin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.138.32003 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1160.138.32002 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1160.138.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1160.138.11001 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

Site Status

1160.138.11009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1160.138.11011 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1160.138.11012 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Site Status

1160.138.11007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1160.138.42002 Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

1160.138.42003 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

Site Status

1160.138.42004 Boehringer Ingelheim Investigational Site

Ostrava, , Czechia

Site Status

1160.138.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1160.138.45001 Boehringer Ingelheim Investigational Site

Copenhagen, , Denmark

Site Status

1160.138.45002 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

1160.138.33004 Boehringer Ingelheim Investigational Site

Bron, , France

Site Status

1160.138.33001 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1160.138.33002 Boehringer Ingelheim Investigational Site

Pessac, , France

Site Status

1160.138.33003 Boehringer Ingelheim Investigational Site

Rennes, , France

Site Status

1160.138.49001 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1160.138.49002 Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

1160.138.49004 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

1160.138.49003 Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

Site Status

1160.138.49010 Boehringer Ingelheim Investigational Site

Witten, , Germany

Site Status

1160.138.31002 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1160.138.31004 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

Site Status

1160.138.47002 Boehringer Ingelheim Investigational Site

Bergen, , Norway

Site Status

1160.138.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1160.138.48004 Boehringer Ingelheim Investigational Site

Gdansk, , Poland

Site Status

1160.138.48003 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.138.48001 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

Site Status

Countries

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Belgium Canada Czechia Denmark France Germany Netherlands Norway Poland

References

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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.

Reference Type DERIVED
PMID: 23991661 (View on PubMed)

Other Identifiers

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2011-002285-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.138

Identifier Type: -

Identifier Source: org_study_id

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