A Phase 2 interventional study of dabigatran etexilate low dose and warfarin 5mg in Thromboembolism and Heart Valve Prosthesis, sponsored by Boehringer Ingelheim. Terminated at 30 sites in 9 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Prevention
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
818 studies on the registry are indexed under Thromboembolism; 97 are open to participants now.
This study's enrollment of 158 is below the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Patient dose determined by dose allocated in 1160.113 and CrCl levels
Drug: dabigatran etexilate low dose · Drug: dabigatran etexilate intermediate dose · Drug: dabigatran etexilate high dose
warfarin doses to maintain INR levels
Drug: warfarin 5mg · Drug: warfarin 1mg · Drug: warfarin 3mg
active treatment (low)
comparator warfarin
active treatment (medium)
comparator warfarin
active treatment (high)
comparator warfarin
Percentage of Patients With Any Adverse Event (AE)
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)
Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
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)
Percentage of Patients With Serious AEs
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)
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
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)
| Milestone | Dabigatran Etexilate (DE) | Warfarin |
|---|---|---|
| Started | 99 | 59 |
| Completed | 95 | 58 |
| Not completed | 4 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
| percentage of participants | Dabigatran Etexilate (DE) | Warfarin |
|---|---|---|
| Percentage of Patients With Any Adverse Event (AE) | 39.4 | 37.3 |
Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events.
| percentage of participants | Dabigatran Etexilate (DE) | Warfarin |
|---|---|---|
| Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | 5.1 | 1.7 |
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
| percentage of participants | Dabigatran Etexilate (DE) | Warfarin |
|---|---|---|
| Percentage of Patients With Serious AEs | 3.0 | 6.8 |
Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis
| percentage of participants | Dabigatran Etexilate (DE) | Warfarin |
|---|---|---|
| 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 |
Collected over From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran Etexilate | — | 3/99 (3%) | 5/99 (5.1%) |
| Warfarin | — | 4/59 (6.8%) | 4/59 (6.8%) |
| Event | Dabigatran Etexilate | Warfarin |
|---|---|---|
| EpilepsyNervous system disorders | 0/99 | 1/59 |
| Atrial fibrillationCardiac disorders | 0/99 | 1/59 |
| Fibrocystic breast diseaseReproductive system and breast disorders | 0/99 | 1/59 |
| Chest painGeneral disorders | 0/99 | 1/59 |
| CellulitisInfections and infestations | 1/99 | 0/59 |
| Cardiac failure congestiveCardiac disorders | 1/99 | 0/59 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/99 | 0/59 |
| CholecystitisHepatobiliary disorders | 1/99 | 0/59 |
| Renal colicRenal and urinary disorders | 1/99 | 0/59 |
| Event | Dabigatran Etexilate | Warfarin |
|---|---|---|
| HypertensionVascular disorders | 5/99 | 4/59 |
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
| Age, Continuous(years) | Dabigatran Etexilate (DE) | Warfarin | Total |
|---|---|---|---|
| Mean | 57.8 ± 8.0 | 56.1 ± 10.1 | 57.2 ± 8.8 |
| Sex: Female, Male(Participants) | Dabigatran Etexilate (DE) | Warfarin | Total |
|---|---|---|---|
| Female | 37 | 19 | 56 |
| Male | 62 | 40 | 102 |
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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