Patients prescribed statins as a primary or secondary prevention of cardiovascular events Circulatory System
Conditions
Interventions
The study will recruit patients from multiple medical sites and randomize them into two arms using Castor software:
Interventional arm be adjusted based on their genotyping results. Physicians will r
Sponsors
United Arab Emirates University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patient (18 years and older) 2. Uses any of the study drugs (atorvastatin or rosuvastatin) 3. Takes part in a follow-up study for at least one year 4. Signs the informed consent
Exclusion criteria
Exclusion criteria: 1. The patient is pregnant or breastfeeding 2. The duration of the index drug is planned to be less than 7 days 3. Hepatic insufficiency: ALT or AST > twice the upper limit of the normal range or patients with liver cirrhosis 4. Renal insufficiency: Serum creatinine >1.5 times the upper limit of the normal range or serum creatinine >2.5 mg/dl in the last 7 days, or severe renal function impairment needing dialysis 5. The subject has an active tumor or a recent cancer diagnosis or is under current chemotherapy treatment 6. Hematologic problems: WBC <2 x 10^9/l; platelet counts <100 x 10^9/l; hematocrit <30% 7. The patient has sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of SAMS is measured using retrospective medical record review at 1 month, 3 months, and 1 year 2. Relevant diagnostic codes for muscle-related disorders (myopathy, myalgia, rhabdomyolysis) are measured using retrospective medical record review at 1 month, 3 months, and 1 year 3. Adverse events are measured using three phone calls at 1 month, 3 months, and 1 year 4. Symptoms of muscle pain are measured using the SAMS CI tool at 1 month, 3 months, and 1 year 5. Severity of muscle pain is measured using the SAMS CI tool at 1 month, 3 months, and 1 year 6. Timing of pain relative to statin initiation is measured using the SAMS CI tool at 1 month, 3 months, and 1 year 7. Pain location and characteristics are measured using the SAMS CI tool at 1 month, 3 months, and 1 year 8. Other potential causes for muscle symptoms are measured using the SAMS CI tool at 1 month, 3 months, and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean LDL cholesterol levels are measured using medical record extraction at baseline and 1 year 2. ASCVD risk score is measured using the ACC/AHA ASCVD Risk Estimator at baseline and 1 year 3. Outcomes in people with an actionable gene-drug interaction are measured using medical record extraction at baseline and 1 year 4. Prespecified margin of greater than 10mg/dL is measured using medical record extraction at baseline and 1 year | — |
Countries
United Arab Emirates
Contacts
Public ContactMais Alqasrawi
Outcome results
None listed