Dual antiplatelet therapy for prolonged secondary prevention of acute coronary events (DEEPSPACE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC04) clopidogrel

  clopidogrel

  (B01AC06) acetylsalicylic acid

  acetylsalicylic acid

  (B01AC22) prasugrel

  prasugrel

  (B01AC24) ticagrelor

  ticagrelor
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• 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)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  The main objective is to compare event rates on DAPT with any of the three P2Y12 antagonists plus aspirin to single antiplatelet therapy (SAPT) with aspirin alone, over 3 years beyond one year after initial coronary event.
• Outcomes:
  Composite of all-cause death, ACS, stroke, or major bleeding. All-cause death, ACS (STEMI, NSTEMI and unstable angina), stroke (ischemic or undefined stroke), major bleeding (intracranial bleeding, upper GI bleeding, other major bleeding).
• Data analysis plan:
  The following analyses will be performed: - Description of patients at baseline and during the 3 years of follow-up, overall and by treatment group with standardized differences before and after adjustment for / matching on hdPS, - A hdPS will be estimated for each comparison (clopidogrel, ticagrelor or prasugrel + aspirin vs aspirin alone) using a multivariable logistic regression model with multiple data dimensions from patients and healthcare reimbursements before index date, - Estimation of outcome incidences during the drug exposure period (all and matched patients) in each treatment group using Kaplan-Meier estimator for death and composite criterion, or cumulative incidence function estimate for other single outcomes in order to take into account death as competing risk, - Comparison of outcome rates between treatment groups using Cox proportional hazard models for death and composite criterion, and Fine and Gray competing risks models for non-fatal outcomes.