European bivalirudin utilisation in practice 2 (EUROVISION 2)

Study identification

• EU PAS number:
  EUPAS7143
• Study ID:
  30897
• Official title and acronym:
  European bivalirudin utilisation in practice 2 (EUROVISION 2)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Finland

  France

  Germany

  Greece

  Netherlands

  Spain

  Sweden

  United Kingdom
• Study description:
  The Medicines Company was requested by the European Medicines Agency (EMA) to conduct a drug utilization study. This simple survey was designed to collect brief data for the last 10 consecutive patients who underwent a PCI and were treated with Angiox at a randomly selected number of institutions. Institutions were asked to fill in a short online questionnaire relating to the use of Angiox. Information for this survey was collected from patient medical records while maintaining patients' anonymity. There was no source data verification at institutions. The EU marketing authorisation for Angiox has now been withdrawn, with effective date 1 July 2018. The marketing authorisation was withdrawn for commercial reasons and not due to any safety, efficacy, quality or compliance concerns.
• Study status:
  Finalised

Research institutions and networks

Institutions

THE MEDICINES COMPANY (Schweiz) GmbH

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/07/2014

Actual: 01/07/2014

Study start date

Planned: 03/11/2014

Actual: 23/10/2014

Data analysis start date

Planned: 04/01/2016

Actual: 04/01/2016

Date of final study report

Planned: 31/03/2016

Actual: 31/03/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The Medicines

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)