The portuguese Survey on anTicoagulated pAtients RegisTer (START-Portugal-Register)

Study type

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

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  ANTITHROMBOTIC AGENTS

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)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  The primary objective of the START-Portugal-Register is to prospectively record the clinical history of adult patients receiving anticoagulant treatment for no more than 30 days, irrespectively of the prescribed drug and the indication for its use.
• Outcomes:
  Major, minor and clinically relevant bleeding complications,Thrombotic events,Adverse events,Mortality (cardiovascular and total). Evaluation of the characteristics of the different available treatments (laboratory tests monitoring, frequency of control visits),Development of cancer,Organ failure.
• Data analysis plan:
  A descriptive analysis will be conducted to all study variables. Categorical variables will be described through absolute and relative frequencies and continuous variables will be described by descriptive statistics using mean and standard deviation, quartiles, median value, minimum and maximum values.Univariate and multivariate analysis will be performed to evaluate the relationship between the presence of risk factors and the occurrence of events of interest, including adverse events.A propensity score model will be applied to compare the safety and efficacy of the different anticoagulant treatments.