Home » Trials » SLCTR/2023/003
Efficacy, safety and cost-effectiveness of Atorvastatin 40 mg versus 80 mg in South Asians with Acute Coronary Syndrome: A Randomized Controlled Trial
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SLCTR Registration Number
SLCTR/2023/003
Date of Registration
The date of last modification
Jul 07, 2023
Scientific Title of Trial
Efficacy, safety and cost-effectiveness of Atorvastatin 40 mg versus 80 mg in South Asians with Acute Coronary Syndrome: A Randomized Controlled Trial
Public Title of Trial
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
Disease or Health Condition(s) Studied
Acute Coronary Syndrome
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1289-2297
Any other number(s) assigned to the trial and issuing authority
P/28/05/2022: ERC, Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
Is atorvastatin 40 mg over 80 mg efficacious, safe and cost-effective and safe in reducing LDL-C levels to the target level and reducing major adverse cardiovascular events (MACE) in South Asians presenting with acute coronary syndromes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Dose comparison
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 4
Intervention(s) planned
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 a random number generator. After randomization, one group will receive atorvastatin dose of 40 mg once daily for 6 months, and the other group will receive atorvastatin dose of 80 mg once daily for 6 months.
All the patients will be assessed for their LDL-c levels at 12 weeks, if there is a lack of efficacy in reaching the target, the atorvastatin dose will adjust (increase to 80mg) in order to reach the targeted LDL-c and they will be re-evaluated at 16th week.
Inclusion 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)
Primary outcome(s)
|
1.
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 outcome(s)
|
1.
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
|
[ At 6 weeks, 12 weeks, and 24 weeks from starting intervention ] |
|
2.
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 ] |
Target number/sample size
78 (39 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2023-03-04
Anticipated end date
2024-02-28
Date of first enrollment
2023-05-24
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2022-08-09
Approval number
P/28/05/2022
Details of Ethics Review Committee
| Name: | ERC, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Nilshan Fernando
Registrar in Clinical Medicine
Professorial Medical Unit
Colombo North Teaching Hospital
Ragama
0777043264
0777043264
nilshan.fernando@gmail.com
Contact Person for Public Queries
Prof. Chamila Mettananda
Professor in Pharmacology
Specialist in Internal Medicine
Department of Pharmacology
Faculty of Medicine
University of Kelaniya
0714816310
0714816310
chamilametta@hotmail.com chamila@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
Version 2: Dated 15/07/2022
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
