RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02596230
• Date of registration: 28/10/2015
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• 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
• Date of first enrolment: November 5, 2015
• Target sample size: 7797
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02596230
• Study type: Observational

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Czechia, Egypt, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Latvia, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Venous Thromboembolism

Primary Outcome(s)

Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality [Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 1: Index Event [Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 1: Sex [Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 1: Anticoagulant Treatment [Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs) [Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 1: Age [Time Frame: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Secondary Outcome(s)

Objective 2: Incidence Rate of VTE-related Mortality [Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 2: Incidence Rate of Recurrent DVT and/or PE [Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Objective 2: Incidence Rate of All-cause Mortality [Time Frame: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).]

Secondary ID(s)

1160.188

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02596230