Acute Coronary Syndrome
Conditions
Interventions
The study will be conducted at the University Medical Unit, CNTH. All eligible patients, to whom physicians decided to start on high intensity statin doses will be randomly allocated to two groups by
Sponsors
Medical Unit, Colombo North Teaching Hospital
Eligibility
Inclusion criteria
Inclusion criteria: * Male or female patient * Aged more than or equal to 18 years * Patients with incident acute coronary syndromes (ACS) as defined by American Heart Association/ American College of Cardiology guideline in 2014 • Patients with ability to understand and follow study related instructions
Exclusion criteria
Exclusion criteria: • Patients with familial hypercholesterolemia • Patients with diagnosed type 2 diabetes mellitus at screening visit • Patients with diagnosed chronic kidney disease (CKD) at screening visit • Patients who are already on statin therapy • Patients with known hypersensitivity to the study treatment • Patients receiving concomitant treatment with cytochrome P450 3A4 (CYP3A4) inhibitors (only the strong inhibitors will be considered here 2. The list is provided below: Adagrasib, Atazanavir, Ceritinib, Clarithromycin, Cobicistat and cobicistat-containing coformulations, Darunavir, Idelalisib, Indinavir, Itraconazole, Ketoconazole, Levoketoconazole, Lonafarnib, Lopinavir, Mifepristone, Nefazodone, Nelfinavir, Nirmatrelvir-ritonavir, Ombitasvir-paritaprevir-ritonavir, Ombitasvir-paritaprevir-ritonavir plus dasabuvir, Posaconazole, Ritonavir and ritonavir-containing coformulations, Saquinavir, Telithromycin, Tucatinib, Voriconazole) • Pregnant and/ or lactating mothers • Any other condition or therapy, which would make the patient unsuitable for this study will not allow participation for the full planned study period (e.g. active malignancy or other or other condition limiting life expectancy to <12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of LDL-c <70 mg/dL or non-HDL-c <100 mg/dL in the lipid profile [At 6 weeks, 12 weeks, and 24 weeks from starting intervention ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the atorvastatin doses All the patients will be followed up at clinic visits and if they developed a MACE, it will be recorded. MACE will be diagnosed and classified according to the AHA guideline, 2014 Safety profile assessment Will be assessed if the patients present with relevant symptoms and signs - Clinical – nausea, vomiting, liver related symptoms with elevated LFT >3 times ULN - Muscle related symptoms with CPK rise > 10 times ULN - CPK rise >10 times - Hypersensitivity - Clinician diagnosed ATN - New onset diabetes mellitus [At 6 weeks, 12 weeks, and 24 weeks from starting intervention] The total cost for medication per patient The mean cost to reduce LDL-C levels to the target will be calculated and it will be compared with the cost of the standard care. [ At 6 months from starting the intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactNilshan Fernando
Registrar in Clinical Medicine
Outcome results
None listed