Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

WARFARIN
ACENOCOUMAROL
FLUINDIONE
HEPARIN
LOW MOLECULAR WEIGHT HEPARIN CALCIUM
LOW MOLECULAR WEIGHT HEPARIN SODIUM
FONDAPARINUX
ARGATROBAN
APIXABAN
RIVAROXABAN

Medical condition to be studied

Venous thrombosis
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

24000
Study design details

Main study objective

To describe anticoagulant treatment patterns and outcomes in patients with venous thromboembolism (VTE), using the French national health data system (SNDS), in two phases. Phase 1 involves descriptive analyses of patients’ characteristics and treatment patterns for VTE patients, with and without active cancer. Phase 2 involves comparative effectiveness and safety analyses (only if powered)

Outcomes

Primary efficacy, Recurrent VTE Primary safety, Major Bleeding, Treatment discontinuation, Treatment switching

Data analysis plan

Phase I of this study would be descriptive in nature, including the number, percentage of patients who discontinue, and switch treatment. Patient characteristics will be summarised using numbers and percentages for categorical values and descriptive statistics (mean, SD, median, minimum, maximum and IQR) for continuous. Descriptive analyses will also be performed for specific subgroups. Phase II involves comparative safety and analyses, which for this study includes a number of clinical endpoints (recurrent VTE, major bleeding). Subgroup analyses are also planned.