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ClinicalTrials.gov Identifier: NCT01505881
Recruitment Status : Terminated
First Posted : January 9, 2012
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Thromboembolism
Heart Valve Prosthesis
Interventions Drug: dabigatran etexilate low dose
Drug: warfarin 5mg
Drug: dabigatran etexilate intermediate dose
Drug: warfarin 1mg
Drug: dabigatran etexilate high dose
Drug: warfarin 3mg
Enrollment 158
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate (DE) Warfarin
Hide Arm/Group Description Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily. Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
Period Title: Overall Study
Started 99 59
Completed 95 58
Not Completed 4 1
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             2             0
Withdrawal by Subject             2             0
Arm/Group Title Dabigatran Etexilate (DE) Warfarin Total
Hide Arm/Group Description Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator Total of all reporting groups
Overall Number of Baseline Participants 99 59 158
Hide Baseline Analysis Population Description
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 59 participants 158 participants
57.8  (8.0) 56.1  (10.1) 57.2  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 59 participants 158 participants
Female
37
  37.4%
19
  32.2%
56
  35.4%
Male
62
  62.6%
40
  67.8%
102
  64.6%
1.Primary Outcome
Title Percentage of Patients With Any Adverse Event (AE)
Hide Description Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
Time Frame From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Arm/Group Title Dabigatran Etexilate (DE) Warfarin
Hide Arm/Group Description:
Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
Overall Number of Participants Analyzed 99 59
Measure Type: Number
Unit of Measure: percentage of participants
39.4 37.3
2.Secondary Outcome
Title Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
Hide Description

Percentage of patients with Adverse Events leading to discontinuation of trial drug.

Prespecified clinical outcome events were not recorded as Adverse Events.

Time Frame From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Arm/Group Title Dabigatran Etexilate (DE) Warfarin
Hide Arm/Group Description:
Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator.
Overall Number of Participants Analyzed 99 59
Measure Type: Number
Unit of Measure: percentage of participants
5.1 1.7
3.Secondary Outcome
Title Percentage of Patients With Serious AEs
Hide Description Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
Time Frame From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Arm/Group Title Dabigatran Etexilate (DE) Warfarin
Hide Arm/Group Description:
Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
Overall Number of Participants Analyzed 99 59
Measure Type: Number
Unit of Measure: percentage of participants
3.0 6.8
4.Secondary Outcome
Title Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Hide Description

Clinical efficacy outcome events presented are:

Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Arm/Group Title Dabigatran Etexilate (DE) Warfarin
Hide Arm/Group Description:
Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
Overall Number of Participants Analyzed 99 59
Measure Type: Number
Unit of Measure: percentage of participants
Death 0.0 1.7
Venous thromboembolism 0.0 0.0
Myocardial Infarction 1.0 0.0
Transient Ischaemic Attack 1.0 0.0
Stroke 3.0 0.0
Systemic embolism 0.0 0.0
Valve thrombosis 2.0 0.0
Time Frame From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Adverse Event Reporting Description Patients are presented according to the treatment they received except for 2 patients, who mistakenly switched to study warfarin during the study. These patients are presented under the Dabigatran columns only.
 
Arm/Group Title Dabigatran Etexilate Warfarin
Hide Arm/Group Description Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
All-Cause Mortality
Dabigatran Etexilate Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   3/99 (3.03%)   4/59 (6.78%) 
Cardiac disorders     
Atrial fibrillation  1  0/99 (0.00%)  1/59 (1.69%) 
Cardiac failure congestive  1  1/99 (1.01%)  0/59 (0.00%) 
General disorders     
Chest pain  1  0/99 (0.00%)  1/59 (1.69%) 
Hepatobiliary disorders     
Cholecystitis  1  1/99 (1.01%)  0/59 (0.00%) 
Infections and infestations     
Cellulitis  1  1/99 (1.01%)  0/59 (0.00%) 
Nervous system disorders     
Epilepsy  1  0/99 (0.00%)  1/59 (1.69%) 
Renal and urinary disorders     
Renal colic  1  1/99 (1.01%)  0/59 (0.00%) 
Reproductive system and breast disorders     
Fibrocystic breast disease  1  0/99 (0.00%)  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  1/99 (1.01%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   5/99 (5.05%)   4/59 (6.78%) 
Vascular disorders     
Hypertension  1  5/99 (5.05%)  4/59 (6.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
This study was terminated prematurely due to safety concerns arising during conduct of the trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01505881     History of Changes
Other Study ID Numbers: 1160.138
2011-002285-21 ( EudraCT Number: EudraCT )
First Submitted: January 5, 2012
First Posted: January 9, 2012
Results First Submitted: June 6, 2014
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014