Post-discharge Clinical and Economic Outcomes Among Patients with ACS Managed with PCI and treated with Prasugrel versus Ticagrelor (H7T-MC-B023)

Study identification

• EU PAS number:
  EUPAS9949
• Study ID:
  9950
• Official title and acronym:
  Post-discharge Clinical and Economic Outcomes Among Patients with ACS Managed with PCI and treated with Prasugrel versus Ticagrelor (H7T-MC-B023)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective cohort study using the Prometix Lx claims database to compare clinical and economic outcomes and treatment patterns among patients treated with prasugrel and those treated with ticagrelor. The primary study population will be patients with ACS managed with PCI who have no prior TIA or stroke (that is, indicated population for treatment with prasugrel). The primary study objective is to compareNACE up to one year post-discharge from an index hospitalisation. The main study hypothesis will be to show that prasugrel is associated with non-inferior outcomes at 1 year compared to ticagrelor. Secondaryendpoints include clinical and economic outcomes and treatment patterns through 30 days, 6 months, and 1 year post index hospitalization discharge. Data will be assessed before and after adjustment for baseline risk differences via propensity score matching. The overall ACS-PCI population, as well as a subgroup of the primary population aged <75 years or >75 years with diabetes or prior MI, will be assessed.
• Study status:
  Finalised

Research institutions and networks

Institutions

PPD Evidera

Sweden

United Kingdom

United States

Study timelines

Date when funding contract was signed

Planned:12/12/2013

Actual:12/12/2013

Study start date

Planned:01/05/2014

Actual:02/06/2014

Data analysis start date

Planned:15/05/2014

Actual:08/06/2014

Date of interim report, if expected

Planned:01/01/2015

Actual:27/02/2015

Date of final study report

Planned:31/03/2015

Actual:31/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  No