Secondary Prevention of Venous Thrombo Embolism (VTE).
- Registration Number
- NCT00329238
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2867
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran Dabigatran Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements Warfarin (INR of 2.0-3.0) Warfarin Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
- Primary Outcome Measures
Name Time Method Composite of Recurrent VTE or VTE Death at 36 Months 36 months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Composite of Recurrent VTE or VTE Death at 18 Months 18 months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
- Secondary Outcome Measures
Name Time Method Deaths Related to VTE at 36 Months 36 months Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Deaths of All Causes at 36 Months 36 months Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Composite of Recurrent VTE or All Cause Death at 36 Months 36 months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Composite of Recurrent VTE or All Cause Death at 18 Months 18 months Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Deep Vein Thrombosis (DVT) at 36 Months 36 months Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Deaths of All Causes at 18 Months 18 months Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Laboratory Analysis 18 months + 30 days follow up Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
Deaths Related to VTE at 18 Months 18 months Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
DVT at 18 Months 18 months Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Number of Participants With Definite Acute Coronary Syndrome (ACS) day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
Symptomatic Pulmonary Embolism (PE) at 36 Months 36 months Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Symptomatic Pulmonary Embolism (PE) at 18 Months 18 months Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Number of Participants With Bleeding Events first intake of study drug until 6 days following last intake of study drug MBE (major bleeding event) if it fulfilled at least one of the following criteria
* Fatal bleeding
* Symptomatic bleeding in a critical area or organ.
* Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs
CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria
* Spontaneous skin haematoma ≥25 cm2
* Spontaneous nose bleed \>5 min duration
* Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting \>24 h
* Spontaneous rectal bleeding
* Gingival bleeding \>5 min
* Bleeding leading to hospitalisation or requiring surgical treatment
* Bleeding leading to a transfusion of \<2 units of whole blood or red cells
* Any other bleeding event considered clinically relevant by the investigator
Trial Locations
- Locations (275)
1160.47.01035 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
1160.47.01056 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
1160.47.01044 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
1160.47.01019 Boehringer Ingelheim Investigational Site
🇺🇸Augusta, Georgia, United States
1160.47.01008 Boehringer Ingelheim Investigational Site
🇺🇸Decatur, Georgia, United States
1160.47.01014 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1160.47.01018 Boehringer Ingelheim Investigational Site
🇺🇸Roxbury Crossing, Massachusetts, United States
1160.47.01023 Boehringer Ingelheim Investigational Site
🇺🇸Detroit, Michigan, United States
1160.47.01009 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis Park, Minnesota, United States
1160.47.01031 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
Scroll for more (265 remaining)1160.47.01035 Boehringer Ingelheim Investigational Site🇺🇸Mobile, Alabama, United States