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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02596230




Registration number
NCT02596230
Ethics application status
Date submitted
28/10/2015
Date registered
4/11/2015
Date last updated
19/04/2019

Titles & IDs
Public title
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
Scientific title
Characterization of Patients Following Acute Venous Thromboembolism (VTE) and Safety and Effectiveness of Dabigatran Etexilate (DE) in the Treatment and Secondary Prevention of Acute Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Comparison to Vitamin K Antagonist (VKA) in Routine Clinical Practice - RE-COVERY DVT/PE
Secondary ID [1] 0 0
1160.188
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with acute VTE - Patients will be enrolled for cross sectional characterization of baseline characteristics

Dabigatran - Patients treated with dabigatran for acute VTE will be followed for one year

vitamin K antagonist - Patients treated with VKA for acute VTE will be followed for one year

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demographic information (age) for Objective 1 patients
Timepoint [1] 0 0
baseline
Primary outcome [2] 0 0
Demographic information (gender) for Objective 1 patients
Timepoint [2] 0 0
baseline
Primary outcome [3] 0 0
International Society of Thrombosis and Haemostasis (ISTH) Major bleeding and ISTH clinically relevant non major bleeding (CRNMB) in Objective 2 patients
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
symptomatic recurrent VTE including VTE-related mortality in Objective 2 patients
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
Anticoagulation treatment choice for VTE for Objective 1 patients
Timepoint [5] 0 0
baseline
Primary outcome [6] 0 0
Venous thromboembolism (VTE) presentation at baseline for Objective 1 patients
Timepoint [6] 0 0
baseline
Secondary outcome [1] 0 0
Recurrent DVT and PE in Objective 2 patients
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
VTE-related mortality in Objective 2 patients
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
all-cause mortality in Objective 2 patients
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Recurrent deep vein thrombosis (DVT) in Objective 2 patients
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Recurrent pulmonary embolism (PE) in Objective 2 patients
Timepoint [5] 0 0
12 months

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Written informed consent provided by the patient in accordance with local regulations

2. Diagnosis of an acute DVT and/or PE (For objective 1, assessment of patient for study
participation should be done ideally within 14 days but not more than 6 months after
diagnosis of the acute VTE. For Objective 2, patient assessment should occur ideally
within 14 days but not more than 30 days from diagnosis)

3. Age >= 18 years

4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months

5. For Objective 2, dabigatran and vitamin K antagonist patients should be available for
follow-up data collection
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Need for anticoagulation therapy for conditions other than venous thromboembolism
(VTE)

2. Current participation in a clinical trial for VTE indication or current use of an
unapproved drug

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RE-COVERY is a large, multi-national, multi-center observational study based on new data
collection. The study will enroll and characterize patients within 30 days of being diagnosed
with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize
the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for
cross-sectional characterization of the VTE patient population. Objective 2 will compare the
safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison
to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for
the occurrence of outcome events for up to one year.
Trial website
https://clinicaltrials.gov/show/NCT02596230
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications