Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel or Prasugrel during the Index Hospitalisation in Sweden (H7T-MC-B010)

Study identification

• EU PAS number:
  EUPAS5934
• Study ID:
  20448
• Official title and acronym:
  Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel or Prasugrel during the Index Hospitalisation in Sweden (H7T-MC-B010)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This is a retrospective analysis using data collected within the SCAAR registry. This noninterventional cohort study aimed to compare bleeding risks in prasugrel-treated and only-clopidogreltreated patients in the ACS-PCI population. The study also provided information regarding bleeding risks in the study population (including patients not diagnosed with ACS) as well as prasugrel treatment patterns during the index hospitalisation in Sweden. Patients were prospectively enrolled into the SCAAR over a 3-year study period and observed only during the index hospitalisation following enrollment.
• Study status:
  Finalised

Research institutions and networks

Institutions

SCAAR

Study timelines

Date when funding contract was signed

Planned:13/12/2010

Actual:13/12/2010

Study start date

Planned:01/05/2010

Actual:01/05/2010

Date of final study report

Planned:15/10/2013

Actual:15/10/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company and Daiichi Sankyo, Inc.

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)