Dabigatran Etexilate in Patients With Mechanical Heart Valves

Phase 2TerminatedNCT01452347

Boehringer Ingelheim328 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

328

Conditions

Heart Valve Diseases

Interventions

warfarin 1mgDRUG

comparator warfarin

dabigatran etexilate intermediate doseDRUG

active treatment (medium)

dabigatran etexilate low doseDRUG

active treatment (low)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Patients aged 18-75 2. Patients who have received a bileaflet mechanical heart valve Exclusion criteria: 1. Prior valve surgery 2. Uncontrolled hypertension 3. severe renal impairment 4. active liver disease 5. increased risk of bleeding

Locations (40)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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1160.113.32003 Boehringer Ingelheim Investigational Site

Brussels, Belgium

1160.113.32007 Boehringer Ingelheim Investigational Site

Brussels, Belgium

1160.113.32002 Boehringer Ingelheim Investigational Site

Genk, Belgium

1160.113.32005 Boehringer Ingelheim Investigational Site

Ghent, Belgium

1160.113.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

1160.113.11002 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

1160.113.11006 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

1160.113.11001 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

1160.113.11009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1160.113.11011 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

...and 30 more locations

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 12