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Clinical Trial Details

Trial ID: L4138
Source ID: NCT03939624
Associated Drug: Sodium-Glucose Cotransporter 2 (Sglt2) Inhibitors
Title: Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors and Risk of Cardiovascular Events
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes|Myocardial Infarction|Ischemic Stroke|Cardiovascular Death|Heart Failure|All-Cause Mortality
Interventions: DRUG: Sodium-glucose cotransporter 2 (SGLT2) inhibitors|DRUG: Dipeptidyl peptidase-4 (DPP-4) inhibitors
Outcome Measures: Primary: Myocardial infarction, Patients hospitalized for myocardial infarction recorded as the most responsible diagnosis or present on admission in the hospitalization record with the following ICD-10-CA codes: I21.x., Patients will be followed from the date of study cohort entry until hospitalization for myocardial infarction, treatment discontinuation, death, end of healthcare coverage, or for up to 64 months, whichever occurs first.|Ischemic stroke, Patients hospitalized for ischemic stroke recorded as the most responsible diagnosis or present on admission in the hospitalization record with the following ICD-10-CA codes: I63.x, I64.x., Patients will be followed from the date of study cohort entry until hospitalization for ischemic stroke, treatment discontinuation, death, end of healthcare coverage, or for up to 64 months, whichever occurs first.|Cardiovascular death, Cardiovascular death will be defined using the following algorithm: * In-hospital death with a cardiovascular diagnosis (ICD-10-CA: I00.x-I77.x (except I46.9)) recorded as the most responsible diagnosis or present on admission; or * Out-of-hospital death (including death in the emergency department) without: * Documentation of cancer (ICD-9-CM: 140-172, 174-209; ICD-10-CA: C00-C43, C45-C97) in hospital, emergency department or physician claims data in the prior year; or * Documentation of trauma (ICD-9-CM: 800-999, E000-E999; ICD-10-CA: S00-T98, V01-Y98) in hospital, emergency department or physician claims data in the preceding month. In a sensitivity analysis, the algorithm will be validated in the sites with access to vital statistics data with cause of death., Patients will be followed from the date of study cohort entry until death, treatment discontinuation, end of healthcare coverage, or for up to 64 months, whichever occurs first. | Secondary: All-cause mortality, Patients will be followed from the date of study cohort entry until death, treatment discontinuation, end of healthcare coverage, or for up to 64 months, whichever occurs first.|Heart failure, Patients hospitalized for heart failure recorded as the most responsible diagnosis in the hospitalization record with the following ICD-10-CA codes: I11.0, I13.0, I13.2, I50.x., Patients will be followed from the date of study cohort entry until hospitalization for heart failure, treatment discontinuation, death, end of healthcare coverage, or for up to 64 months, whichever occurs first.
Sponsor/Collaborators: Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES | Collaborators: Drug Safety and Effectiveness Network, Canada|Canadian Institutes of Health Research (CIHR)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 419734
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-10-01
Completion Date: 2019-10-01
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, H3T1E2, Canada
URL: https://clinicaltrials.gov/show/NCT03939624