ThromboembolismPhase 2NCT01505881

Follow on Study From RE-ALIGN

A Phase 2 study testing dabigatran etexilate low dose, warfarin 5mg and dabigatran etexilate intermediate dose in people with Thromboembolism and Heart Valve Prosthesis, run by Boehringer Ingelheim at 30 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Thromboembolism, Heart Valve Prosthesis
What is being tested?: dabigatran etexilate low dose, warfarin 5mg and dabigatran etexilate intermediate dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 30 sitesin 9 countries
Study dates: Dec 2011to Jun 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completed study 1160.113 per protocol
Continuing need for anticoagulation

Who cannot join

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

Trial locations and contacts

30 sites in 9 countries.

Country

City, postcode or hospital

30 sites in 9 countries

Canada5 sites

1160.138.11009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.138.11011 Boehringer Ingelheim Investigational Site
London, Ontario
1160.138.11012 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1160.138.11001 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
1160.138.11007 Boehringer Ingelheim Investigational Site
Toronto, Ontario

Other trials in Canada

Germany5 sites

1160.138.49001 Boehringer Ingelheim Investigational Site
Dresden
1160.138.49002 Boehringer Ingelheim Investigational Site
Essen
1160.138.49004 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1160.138.49003 Boehringer Ingelheim Investigational Site
Heidelberg
1160.138.49010 Boehringer Ingelheim Investigational Site
Witten

Other trials in Germany

Czechia4 sites

1160.138.42002 Boehringer Ingelheim Investigational Site
Brno
1160.138.42003 Boehringer Ingelheim Investigational Site
Olomouc
1160.138.42004 Boehringer Ingelheim Investigational Site
Ostrava
1160.138.42001 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

France4 sites

1160.138.33004 Boehringer Ingelheim Investigational Site
Bron
1160.138.33001 Boehringer Ingelheim Investigational Site
Paris
1160.138.33002 Boehringer Ingelheim Investigational Site
Pessac
1160.138.33003 Boehringer Ingelheim Investigational Site
Rennes

Other trials in France

Belgium3 sites

1160.138.32003 Boehringer Ingelheim Investigational Site
Brussels
1160.138.32002 Boehringer Ingelheim Investigational Site
Genk
1160.138.32001 Boehringer Ingelheim Investigational Site
Leuven

Other trials in Belgium

Poland3 sites

1160.138.48004 Boehringer Ingelheim Investigational Site
Gdansk
1160.138.48003 Boehringer Ingelheim Investigational Site
Warsaw
1160.138.48001 Boehringer Ingelheim Investigational Site
Wroclaw

Other trials in Poland

Denmark2 sites

1160.138.45001 Boehringer Ingelheim Investigational Site
Copenhagen
1160.138.45002 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

Netherlands2 sites

1160.138.31002 Boehringer Ingelheim Investigational Site
Amsterdam
1160.138.31004 Boehringer Ingelheim Investigational Site
Breda

Other trials in Netherlands

Norway2 sites

1160.138.47002 Boehringer Ingelheim Investigational Site
Bergen
1160.138.47001 Boehringer Ingelheim Investigational Site
Oslo

Other trials in Norway

About this study

Official title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve

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

Conditions: Thromboembolism, Heart Valve Prosthesis
Being tested: dabigatran etexilate low dose, warfarin 5mg, dabigatran etexilate intermediate dose, warfarin 1mg, dabigatran etexilate high dose
Medical subject headings: Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dabigatran etexilate low doseDrug
active treatment (low)
warfarin 5mgDrug
comparator warfarin
dabigatran etexilate intermediate doseDrug
active treatment (medium)
warfarin 1mgDrug
comparator warfarin
dabigatran etexilate high doseDrug
active treatment (high)
warfarin 3mgDrug
comparator warfarin

Study groups in NCT01505881
Study group	Role	What they receive
Dabigatran etexilate	Experimental	Patient dose determined by dose allocated in 1160.113 and CrCl levels Receives: Drug: dabigatran etexilate low dose; Drug: dabigatran etexilate intermediate dose; Drug: dabigatran etexilate high dose
warfarin	Active comparator	warfarin doses to maintain INR levels Receives: Drug: warfarin 5mg; Drug: warfarin 1mg; Drug: warfarin 3mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Any Adverse Event (AE)
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
Measured: 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
Percentage of patients with Adverse Events leading to discontinuation of trial drug.
Prespecified clinical outcome events were not recorded as Adverse Events.
Measured: 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
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
Measured: 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.
Clinical efficacy outcome events presented are:
Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis
Measured: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2013

First posted9 Jan 2012 (estimated)
Study startDec 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ThromboembolismStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01505881
Sponsor's protocol ID: 1160.138
Other IDs: 2011-002285-21
Status last verified: Jul 2014
First submitted: 5 Jan 2012
Last updated: 11 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23991661

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingObservational study
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature
Active, not recruitingObservational study
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Sepsis, Venous Thromboembolism

All Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
ClinicalTrials.gov ID: NCT01505881
Acronym / sponsor ID: 1160.138
Conditions: Thromboembolism, Heart Valve Prosthesis
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 158 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 9 Jan 2012 (estimated)
Results: Posted 11 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dabigatran etexilate	Experimental	Drug: dabigatran etexilate low dose, Drug: dabigatran etexilate intermediate dose, Drug: dabigatran etexilate high dosePatient dose determined by dose allocated in 1160.113 and CrCl levels
warfarin	Active comparator	Drug: warfarin 5mg, Drug: warfarin 1mg, Drug: warfarin 3mgwarfarin doses to maintain INR levels

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Completed study 1160.113 per protocol
Continuing need for anticoagulation

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dabigatran etexilate low doseactive treatment (low)	Drug	Dabigatran etexilate
warfarin 5mgcomparator warfarin	Drug	warfarin
dabigatran etexilate intermediate doseactive treatment (medium)	Drug	Dabigatran etexilate
warfarin 1mgcomparator warfarin	Drug	warfarin
dabigatran etexilate high doseactive treatment (high)	Drug	Dabigatran etexilate
warfarin 3mgcomparator warfarin	Drug	warfarin

Primary outcome

Percentage of Patients With Any Adverse Event (AE)
Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.

3 secondary outcomes

Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
Time frame: 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
Time frame: 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.
Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Results and safety

Results posted to the registry on 11 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran Etexilate (DE)	99	95
Warfarin	59	58

Primary outcome: Percentage of Patients With Any Adverse Event (AE)

Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days). Number. Unit: percentage of participants

Measure	Dabigatran Etexilate (DE) n = 99	Warfarin n = 59
Value	39.4	37.3

Population analysed: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate	3 of 99 (3%)	5 of 99 (5.1%)	Not reported
Warfarin	4 of 59 (6.8%)	4 of 59 (6.8%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated prematurely due to safety concerns arising during conduct of the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23991661Eikelboom 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.

Related trials for Thromboembolism

RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingObservational study
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature
Active, not recruitingObservational study
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Sepsis, Venous Thromboembolism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

30 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Canada, Germany, Czechia, France, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Any Adverse Event (AE) (time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01505881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014; AzTrials last refreshed its copy on 27 Oct 2026.