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Anticoagulant

Dabigatran etexilate for Heart Valve Disease (RE-ALIGN Trial)

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
+1 more
Secondary outcome measures
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dabigatran etexilateExperimental Treatment3 Interventions
Patient dose dependent on screening CrCl levels and TT
Group II: warfarinActive Control3 Interventions
warfarin doses to maintain INR levels

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Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,357,199 Total Patients Enrolled
~24 spots leftby Sep 2025
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