Effectiveness and safety of low dose rivaroxaban plus aspirin in patients with Chronic Coronary Syndrome and high ischemic risk. (Dutch CCS Registry)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  National, multicentre, prospective, single-arm, observational study

Study drug and medical condition

• Name of medicine:
  XARELTO
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC06) acetylsalicylic acid

  acetylsalicylic acid
• Medical condition to be studied:
  Coronary artery disease

  Peripheral arterial occlusive disease

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The main objective of the study is to describe the impact in terms of effectiveness and safety of the combination treatment of rivaroxaban 2.5 mg twice daily in combination with Acetyl Salicylic Acid on clinical outcomes and practices in a real-life Dutch patient population that are at high risk of ischemic events.
• Outcomes:
  The primary effectiveness endpoint is a composite of: - Major Adverse Cardiac Events (MACE including ischemic stroke, cardiovascular mortality and myocardial infarction) - Clinically driven coronary, peripheral, or carotid revascularization - Stent thrombosis during one-year follow-up The primary safety endpoint is Major Bleeding during one-year follow-up. Occurrence (and date) stroke, myocardial infarction, cardiovascular death, coronary revascularization procedures (PCI, CABG), peripheral revascularization procedures, carotid revascularization procedures, peripheral revascularization procedures, minor bleeding complications (according to ISTH) All bleeding events including minor bleedings according to ISTH definitions will be reported
• Data analysis plan:
  The statistical analyses will be explorative and descriptive. The study is not aimed to test pre-defined hypotheses. Analyses of the clinical outcomes will be performed using the full-analysis-set (FAS) population, including all patients that received at least one dose of the study drug.