Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-crossover
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(R01A) DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Population studied

Short description of the study population

For MI cases: Patients who have first diagnosed MI (incident cases) within 45 days prior to inclusion, diagnosis made by board-certified cardiologists.
For stroke cases: Patients who have first haemorrhagic or ischemic stroke within 45 days prior to inclusion, documented by CT scan or MRI, and diagnosis made by a specialist (neurologist, cardiologist, internal medicine physician).

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)

Estimated number of subjects

2700
Study design details

Main study objective

The main objective of the study is to determine whether exposure to vasoconstrictors is associated with an increased risk of occurrence of stroke and/or of myocardial infarction. The endpoint is composite: - Haemorrhagic or ischemic Stroke - Myocardial infarction

Outcomes

The endpoint is composite: - Haemorrhagic or ischemic Stroke - Myocardial infarction, Other objectives:- To determine if exposure to vasoconstrictors is associated with an increased risk of occurrence of myocardial infarction- To determine whether exposure to vasoconstrictors is associated with an increased risk of occurrence of haemorrhagic or ischemic stroke

Data analysis plan

The analytic plan will proceed through:- Description of patients and participation rates- Description of cases of MI and stroke- Description of non-participants (including dead patients)- Description of risk factors and co-morbidities in cases of MI and stroke - Description of vasoconstrictors (VCs) use- Description of time varying risk factors variables- Unadjusted comparison of VCs use and no VCs use in risk and referent time windows in cases - Adjusted comparison of VCs use and no VCs use in risk and referent time windows in cases- Collinearity analysis- Sensitivity analysisA sample size of 2700 patients (1350 MI, 1350 stroke) has been retained under the hypothesis of a detectable odds ratio (between 1.51 and 1.76) with 95% confidence and 80% power in different assumptions of exposure in the reference period (1 or 2% respectively).The statistical analytical plan is developed and approved by the scientific committee.