Efficacy, safety, and cost-effectiveness of atorvastatin 40 mg over 80 mg in reducing LDL-C levels to the target level and reducing major adverse cardiovascular events (MACE) in South Asians presenting with acute coronary syndromes: A Randomized Controlled Trial
- Conditions
- Acute Coronary Syndrome
- Registration Number
- SLCTR/2023/003
- Lead Sponsor
- Medical Unit, Colombo North Teaching Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
* 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
•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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br><br>]<br>
- Secondary Outcome Measures
Name Time Method Safety and tolerability of the atorvastatin doses <br><br>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<br><br>Safety profile assessment <br>Will be assessed if the patients present with relevant symptoms and signs<br><br>- Clinical – nausea, vomiting, liver related symptoms with elevated LFT >3 times ULN<br><br>- Muscle related symptoms with CPK rise > 10 times ULN<br><br>- CPK rise >10 times<br><br>- Hypersensitivity<br><br>- Clinician diagnosed ATN<br><br>- New onset diabetes mellitus<br> [At 6 weeks, 12 weeks, and 24 weeks from starting intervention]<br>The total cost for medication per patient <br><br>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]<br>