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 type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC22) prasugrel

  prasugrel
• Medical condition to be studied:
  Acute coronary syndrome

  Percutaneous coronary intervention

Population studied

• Short description of the study population:
  Acute Coronary Syndrome (STEMI, NSTEMI, UA) patients at least 18 years of age at time of index Percutaneous Coronary Intervention (PCI) managed by PCI with stent implantation during the index hospitalization between 01 January 2010 and 30 June 2013 and treated with prasugrel or clopidogrel during index hospitalization either prior to, or during the peri-procedural period.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  8606

Study design details

• Main study objective:
  Primary Objective: 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.
• Outcomes:
  Composite and individual components of MACE endpoint (all-cause death,MI, stroke, and unplanned revascularization) at 90 Days. Outcomes for patients regarding demographics, clinical, and angiographic profiles and composite and individual components of MACE at 30, 180, and 365 days following index PCI and difference in rates for bleeding (inpatient and outpatient), stent thrombosis, economic resource utilization (length of stay, rehospitalization rates for MI and bleeding, and applicable costs for hospitalization.
• Data analysis plan:
  The primary endpoint of interest is the first occurrence of MACE within 90 days from date of index PCI. Event-free patients will be censored at 90 days or last contact, whichever comes first. Crude unadjusted 90-day rates of MACE will be calculated for each group using the Kaplan-Meier method, also including index hospital events. Crude rates will be compared between groups using the logrank test. To evaluate the adjusted associations between treatment group (therapy initiation with prasugrel versus clopidogrel) and the primary MACE outcome, hazard ratios will be calculated using Cox proportional hazards regression that are stratified by the propensity to receive either prasugrel or clopidogrel. In addition to age, and gender, this model will include all baseline covariates demonstrating significant differences (p<0.05) between groups. From this logistic regression model, each observation will be assigned a predicted probability for prasugrel treatment.