Dabigatran Etexilate in Patients With Mechanical Heart Valves (RE-ALIGN)
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ClinicalTrials.gov Identifier: NCT01452347 |
Recruitment Status :
Terminated
First Posted : October 14, 2011
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Valve Diseases | Drug: warfarin 1mg Drug: dabigatran etexilate intermediate dose Drug: dabigatran etexilate low dose Drug: warfarin 5mg Drug: dabigatran etexilate high dose Drug: warfarin 3mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 328 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Dabigatran etexilate
Patient dose dependent on screening CrCl levels and TT
|
Drug: dabigatran etexilate intermediate dose
active treatment (medium) Drug: dabigatran etexilate low dose active treatment (low) Drug: dabigatran etexilate high dose active treatment (high) |
Active Comparator: warfarin
warfarin doses to maintain INR levels
|
Drug: warfarin 1mg
comparator warfarin Drug: warfarin 5mg comparator warfarin Drug: warfarin 3mg comparator warfarin |
- 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.
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1 [ Time Frame: 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.
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2 [ Time Frame: 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.
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4 [ Time Frame: 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.
- Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients aged 18-75
- Patients who have received a bileaflet mechanical heart valve
Exclusion criteria:
- Prior valve surgery
- Uncontrolled hypertension
- severe renal impairment
- active liver disease
- increased risk of bleeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452347

Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01452347 |
Other Study ID Numbers: |
1160.113 2010-022685-27 ( EudraCT Number: EudraCT ) |
First Posted: | October 14, 2011 Key Record Dates |
Results First Posted: | August 6, 2014 |
Last Update Posted: | August 6, 2014 |
Last Verified: | July 2014 |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases Warfarin Dabigatran Anticoagulants |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |