Trial Outcomes & Findings for Follow on Study From RE-ALIGN (NCT NCT01505881)
NCT ID: NCT01505881
Last Updated: 2014-07-11
Results Overview
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Results posted on
2014-07-11
Participant Flow
Participant milestones
| Measure |
Dabigatran Etexilate (DE)
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.
|
Warfarin
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 Study
STARTED
|
99
|
59
|
|
Overall Study
COMPLETED
|
95
|
58
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Dabigatran Etexilate (DE)
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.
|
Warfarin
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 Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Follow on Study From RE-ALIGN
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate (DE)
n=99 Participants
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
|
Warfarin
n=59 Participants
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
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
Outcome measures
| Measure |
Dabigatran Etexilate (DE)
n=99 Participants
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.
|
Warfarin
n=59 Participants
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
|
|---|---|---|
|
Percentage of Patients With Any Adverse Event (AE)
|
39.4 percentage of participants
|
37.3 percentage of participants
|
SECONDARY outcome
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events.
Outcome measures
| Measure |
Dabigatran Etexilate (DE)
n=99 Participants
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.
|
Warfarin
n=59 Participants
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
|
|---|---|---|
|
Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
|
5.1 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
Outcome measures
| Measure |
Dabigatran Etexilate (DE)
n=99 Participants
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.
|
Warfarin
n=59 Participants
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
|
|---|---|---|
|
Percentage of Patients With Serious AEs
|
3.0 percentage of participants
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis
Outcome measures
| Measure |
Dabigatran Etexilate (DE)
n=99 Participants
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.
|
Warfarin
n=59 Participants
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
|
|---|---|---|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Death
|
0.0 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Venous thromboembolism
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Myocardial Infarction
|
1.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Transient Ischaemic Attack
|
1.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Stroke
|
3.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Systemic embolism
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Valve thrombosis
|
2.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Dabigatran Etexilate
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Warfarin
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran Etexilate
n=99 participants at risk
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
|
Warfarin
n=59 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
1.0%
1/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
0.00%
0/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
1.7%
1/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
1.7%
1/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
0.00%
0/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
0.00%
0/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
0.00%
0/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Renal and urinary disorders
Renal colic
|
1.0%
1/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
0.00%
0/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
1.7%
1/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
|
General disorders
Chest pain
|
0.00%
0/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
1.7%
1/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
Other adverse events
| Measure |
Dabigatran Etexilate
n=99 participants at risk
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
|
Warfarin
n=59 participants at risk
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
|
|---|---|---|
|
Vascular disorders
Hypertension
|
5.1%
5/99 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
6.8%
4/59 • From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
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.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER