Clinical and Economic Assessment of Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention and Treated with Prasugrel or Clopidogrel using Academic Center Databases (H7T-US-B020)

Study identification

• EU PAS number:
  EUPAS8687
• Study ID:
  11418
• Official title and acronym:
  Clinical and Economic Assessment of Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention and Treated with Prasugrel or Clopidogrel using Academic Center Databases (H7T-US-B020)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To compare major adverse cardiac event (MACE) outcomes (the composite occurrence of all-cause death, MI, stroke, or unplanned coronary revascularization) within 90 days of index PCI in patients with ACS treated with prasugrel or clopidogrel.
• Study status:
  Finalised

Research institutions and networks

Institutions

Icahn School of Medicine at Mount Sinai

Mount Sinai Medical Center New York City, NY USA, Aurora Health Care Milwaukee, WI USA, Christiana Care Health Services Wilmington, DE USA, Cleveland Clinic Cleveland, OH USA, Duke University Durhan, NC USA, Intermountain Heart Institute Murray, UT USA, University of Pittsburgh PIttsburgh, PA USA, Minneapolis Heart Institute Minneapolis, IN

Study timelines

Date when funding contract was signed

Planned:01/07/2014

Actual:01/07/2014

Study start date

Planned:06/08/2014

Actual:29/09/2014

Data analysis start date

Planned:27/02/2015

Actual:28/02/2015

Date of interim report, if expected

Planned:01/03/2015

Date of final study report

Planned:31/03/2015

Actual:30/06/2015

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