Heart Valve DiseasesPhase 2RE-ALIGNNCT01452347

Dabigatran Etexilate in Patients With Mechanical Heart Valves

A Phase 2 study testing warfarin 1mg, dabigatran etexilate intermediate dose and dabigatran etexilate low dose in people with Heart Valve Diseases, run by Boehringer Ingelheim at 40 sites in 10 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 validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Heart Valve Diseases
What is being tested?: warfarin 1mg, dabigatran etexilate intermediate dose and dabigatran etexilate low dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 328 participants
Where: 40 sitesin 10 countries
Study dates: Oct 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

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

Who cannot join

Prior valve surgery
Uncontrolled hypertension
severe renal impairment
active liver disease
increased risk of bleeding

Trial locations and contacts

40 sites in 10 countries.

Country

City, postcode or hospital

40 sites in 10 countries

Canada7 sites

1160.113.11002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.113.11009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.113.11011 Boehringer Ingelheim Investigational Site
London, Ontario
1160.113.11012 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1160.113.11001 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
1160.113.11007 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1160.113.11006 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Germany6 sites

1160.113.49001 Boehringer Ingelheim Investigational Site
Dresden
1160.113.49002 Boehringer Ingelheim Investigational Site
Essen
1160.113.49008 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1160.113.49004 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1160.113.49003 Boehringer Ingelheim Investigational Site
Heidelberg
1160.113.49010 Boehringer Ingelheim Investigational Site
Witten

Other trials in Germany

Belgium5 sites

1160.113.32003 Boehringer Ingelheim Investigational Site
Brussels
1160.113.32007 Boehringer Ingelheim Investigational Site
Brussels
1160.113.32002 Boehringer Ingelheim Investigational Site
Genk
1160.113.32005 Boehringer Ingelheim Investigational Site
Ghent
1160.113.32001 Boehringer Ingelheim Investigational Site
Leuven

Other trials in Belgium

Czechia5 sites

1160.113.42002 Boehringer Ingelheim Investigational Site
Brno
1160.113.42005 Boehringer Ingelheim Investigational Site
Hradec Králové
1160.113.42003 Boehringer Ingelheim Investigational Site
Olomouc
1160.113.42004 Boehringer Ingelheim Investigational Site
Ostrava
1160.113.42001 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

France4 sites

1160.113.33004 Boehringer Ingelheim Investigational Site
Bron
1160.113.33001 Boehringer Ingelheim Investigational Site
Paris
1160.113.33002 Boehringer Ingelheim Investigational Site
Pessac
1160.113.33003 Boehringer Ingelheim Investigational Site
Rennes

Other trials in France

Netherlands3 sites

1160.113.31001 Boehringer Ingelheim Investigational Site
Amsterdam
1160.113.31002 Boehringer Ingelheim Investigational Site
Amsterdam
1160.113.31004 Boehringer Ingelheim Investigational Site
Breda

Other trials in Netherlands

Poland3 sites

1160.113.48004 Boehringer Ingelheim Investigational Site
Gdansk
1160.113.48003 Boehringer Ingelheim Investigational Site
Warsaw
1160.113.48001 Boehringer Ingelheim Investigational Site
Wroclaw

Other trials in Poland

Sweden3 sites

1160.113.46004 Sahlgrenska Universitetssjukhuset
Gothenburg
1160.113.46003 Skånes Universitetssjukhus Lund
Lund
1160.113.46001 Akademiska Sjukhuset
Uppsala

Other trials in Sweden

Denmark2 sites

1160.113.45001 Boehringer Ingelheim Investigational Site
Copenhagen
1160.113.45002 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

Norway2 sites

1160.113.47002 Boehringer Ingelheim Investigational Site
Bergen
1160.113.47001 Boehringer Ingelheim Investigational Site
Oslo

Other trials in Norway

About this study

Official title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

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

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

What participants receive

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

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

Study groups in NCT01452347
Study group	Role	What they receive
Dabigatran etexilate	Experimental	Patient dose dependent on screening CrCl levels and TT Receives: Drug: dabigatran etexilate intermediate dose; Drug: dabigatran etexilate low dose; Drug: dabigatran etexilate high dose
warfarin	Active comparator	warfarin doses to maintain INR levels Receives: Drug: warfarin 1mg; Drug: warfarin 5mg; Drug: warfarin 3mg

What is being measured

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

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Measured: Week 1
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Measured: Week 2
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Measured: Week 4
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).
(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)
Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Measured: Week 12

Secondary outcomes (4)

Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.
Measured: Week 1
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.
Measured: Week 2
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4
Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.
Measured: Week 4
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.
Measured: Week 12

Timeline

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

Oct 2011Jun 2013

First posted14 Oct 2011 (estimated)
Study startOct 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 Heart Valve DiseasesStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01452347
Sponsor's protocol ID: 1160.113
Other IDs: 2010-022685-27
Acronym: RE-ALIGN
Status last verified: Jul 2014
First submitted: 11 Oct 2011
Last updated: 6 Aug 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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All Heart Valve Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt
ClinicalTrials.gov ID: NCT01452347
Acronym / sponsor ID: RE-ALIGN / 1160.113
Conditions: Heart Valve Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 328 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 14 Oct 2011 (estimated)
Results: Posted 6 Aug 2014

Clinical summary

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

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

Study design

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

Arm	Type	Receives
Dabigatran etexilate	Experimental	Drug: dabigatran etexilate intermediate dose, Drug: dabigatran etexilate low dose, Drug: dabigatran etexilate high dosePatient dose dependent on screening CrCl levels and TT
warfarin	Active comparator	Drug: warfarin 1mg, Drug: warfarin 5mg, 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)

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

Key exclusion criteria (5 listed)

Prior valve surgery
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
warfarin 1mgcomparator warfarin	Drug	warfarin
dabigatran etexilate intermediate doseactive treatment (medium)	Drug	Dabigatran etexilate
dabigatran etexilate low doseactive treatment (low)	Drug	Dabigatran etexilate
warfarin 5mgcomparator warfarin	Drug	warfarin
dabigatran etexilate high doseactive treatment (high)	Drug	Dabigatran etexilate
warfarin 3mgcomparator warfarin	Drug	warfarin

Primary outcome

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
Time frame: Week 1
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) . Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
Time frame: Week 2
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
Time frame: Week 4
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
Time frame: Week 12
Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.

4 secondary outcomes

Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
Time frame: Week 1
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
Time frame: Week 2
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4
Time frame: Week 4
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 6 Aug 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)	168	151
Warfarin	84	77

Primary outcome: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1

Time frame: Week 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Observed n = 130	Predicted n = 130
Value	73.86 (43.9)	99.52 (43.9)

Observed vs Predicted: Adjusted Geometric Mean ratio: 74.22 (95% CI 68.08 to 80.91), ANOVA

Population analysed: Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.

Primary outcome: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2

Time frame: Week 2. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Observed n = 26	Predicted n = 26
Value	84.08 (40.2)	99.55 (40.2)

Observed vs Predicted: Adjusted Geometric Mean ratio: 84.46 (95% CI 70.32 to 101.44), ANOVA

Primary outcome: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4

Time frame: Week 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Observed n = 112	Predicted n = 112
Value	104.43 (34.3)	109.36 (34.3)

Observed vs Predicted: Adjusted Geometric Mean ratio: 95.50 (95% CI 88.69 to 102.84), ANOVA

Primary outcome: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12

Time frame: Week 12. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Observed n = 54	Predicted n = 54
Value	108.21 (59.8)	104.80 (59.8)

Observed vs Predicted: Adjusted Geometric Mean ratio: 103.25 (95% CI 86.40 to 123.40), ANOVA

4 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 101 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate	19 of 162 (11.7%)	64 of 162 (39.5%)	Not reported
Warfarin	11 of 89 (12.4%)	38 of 89 (42.7%)	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 6 Aug 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 InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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

40 sites in 10 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 5 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Canada, Germany, Belgium, Czechia, France and 5 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 6 Aug 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?

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 (time frame: Week 1). The study lists 4 primary outcomes in all. 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 NCT01452347, 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 6 Aug 2014.