A multicentre observational, prospective cohort study including patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive cangrelor i.v. transitioning to either clopidogrel, prasugrel or ticagrelor per os (ARCANGELO)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  KENGREXAL
• Study drug International non-proprietary name (INN) or common name:
  CANGRELOR TETRASODIUM

  CLOPIDOGREL

  PRASUGREL

  TICAGRELOR
• Anatomical Therapeutic Chemical (ATC) code:
  (B01) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS

  (B01AC04) clopidogrel

  clopidogrel

  (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:
  1000

Study design details

• Main study objective:
  To assess the safety of cangrelor in a real-world setting, when administered in patients with acute coronary syndromes undergoing PCI. The safety of cangrelor will be based on the incidence of any haemorrhage at 30 days post-PCI.
• Outcomes:
  - Any haemorrhage within 30 days post-PCI; - Moderate to severe haemorrhages according to BARC (type 3-5) ; - Mild haemorrhages according to BARC (type 1-2) ; - Major adverse cardiac events (MACE) ; - Use of oral platelet P2Y12 receptor antagonists ; - Use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors ; - Details of PCI ; - Use of cangrelor ; - Transfusions ; - Adverse events/reactions
• Data analysis plan:
  The results of analyses on primary safety and secondary safety variables, efficacy variables, and all the other remaining variables will be presented by descriptive statistics (frequency count and percentage for categorical variables, number of observations, mean, standard deviation, median, quartiles, minimum and maximum for continuous variables).