One Year Post-discharge Clinical and Economic Outcomes among Patients with ACS Managed with PCI and Treated with Prasugrel versus Clopidogrel (H7T-MC-B022)

Study identification

• EU PAS number:
  EUPAS9953
• Study ID:
  13443
• Official title and acronym:
  One Year Post-discharge Clinical and Economic Outcomes among Patients with ACS Managed with PCI and Treated with Prasugrel versus Clopidogrel (H7T-MC-B022)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective cohort study using the Optum Research Claims Database to compare clinical and economic outcomes and treatment patterns among patients treated with prasugrel and those treated with clopidogrel. The primary study population will be patients with ACS managed with PCI who have no prior TIA or stroke (that is, the indicated population for treatment with prasugrel). Primary study objective is to compare major adverse cardiac events (MACE) up to one year and secondary endpoints will include clinical and economic outcomes and treatment patterns through 1 year post index hospitalisation discharge. Data will be assessed before and after adjustment for baseline risk differences via propensity score matching. The subgroup of the primary population aged <75years or >75 years with diabetes or prior MI, will also be assessed (that is, the population recommended for treatment with prasugrel per USPI).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 31/10/2013

Actual: 31/10/2013

Study start date

Planned: 01/03/2014

Actual: 01/04/2014

Data analysis start date

Planned: 01/05/2014

Actual: 01/06/2014

Date of interim report, if expected

Planned: 01/09/2015

Date of final study report

Planned: 01/10/2015

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