Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel and Prasugrel during the Index Hospitalisation in Germany (H7T-MC-B008)

Study identification

• EU PAS number:
  EUPAS5924
• Study ID:
  20442
• Official title and acronym:
  Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel and Prasugrel during the Index Hospitalisation in Germany (H7T-MC-B008)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a prospective non internvetional cohort study aiming to assess prasugrel treatment patterns (especially as they relate to the timing of loading dose of prasugrel treatment) and to compare bleeding risks(including bleeding risks associated with the timing of loading dose and the overall bleeding risks) between prasugrel and clopedgrel treated patients during index hospitalisation in the ALKK-PCI registry in Germany. Consecutive patienst will be prospectively enrolled into the registry over a three year period, starting 3-4 months after the launch of prasugrel in Germany. Information collected in this registry will be used to address CHMP’s requirements of comparing bleeding risks between prasugrel- treated patients and of describing the treatment patterns of prasugrel.
• Study status:
  Finalised

Research institutions and networks

Institutions

ALKK-ATCs

Study timelines

Date when funding contract was signed

Planned:14/10/2009

Actual:14/10/2009

Study start date

Planned:01/10/2009

Actual:01/10/2009

Date of final study report

Planned:14/01/2013

Actual:16/08/2013

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)