ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of 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

Study identification

• EU PAS number:
  EUPAS11368
• Study ID:
  34224
• Official title and acronym:
  ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of 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
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Austria

  Belgium

  Brazil

  Bulgaria

  Canada

  Chile

  Colombia

  Ecuador

  Egypt

  Germany

  Greece

  Hungary

  Italy

  Korea, Republic of

  Latvia

  Lebanon

  Malaysia

  Mexico

  Netherlands

  New Zealand

  Peru

  Philippines

  Poland

  Portugal

  Romania

  Russian Federation

  Saudi Arabia

  Serbia

  Slovakia

  Slovenia

  Sweden

  Thailand

  Türkiye

  United Arab Emirates

  United Kingdom

  United States

  Viet Nam
• Study description:
  RE-COVERY is a large, multi-national, multi-center non-interventional 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 willcharacterize 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 befollowed up for the occurrence of outcome events for up to one year.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 15/09/2014

Actual: 15/09/2014

Study start date

Planned: 18/01/2016

Actual: 03/02/2016

Date of final study report

Planned: 17/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable