Acute Coronary Syndrome
Conditions
Keywords
Acute Coronary Syndrome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Low-Density Lipoprotein Cholesterol, Cardiovascular Diseases, Drug Therapy, Combination
Brief summary
This study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with acute coronary syndrome (ACS). The study aims to determine whether moderate-intensity statins can provide comparable benefits to high-intensity statins, particularly for patients at higher risk of adverse effects from higher doses. The findings may inform treatment decisions and reduce financial and clinical burdens on patients.
Detailed description
Statins are the cornerstone of therapy for reducing cardiovascular events in patients with atherosclerotic cardiovascular disease. Current guidelines recommend high-intensity statins for patients with ACS to lower LDL-C levels by 50% or more. However, emerging evidence suggests that the benefits of lowering LDL-C may be independent of the statin dose and type. This randomized controlled trial investigates the effectiveness of moderate-intensity statins compared to high-intensity statins in reducing LDL-C levels among local populations. The study also explores whether moderate-intensity statins can mitigate adverse effects, such as myopathy or liver dysfunction, commonly associated with high-intensity statin therapy, particularly in populations with lower baseline LDL-C levels and high statin responsiveness. Participants will be randomly assigned to receive either high-intensity or moderate-intensity statin therapy. The primary outcome measure is the percentage of participants achieving an LDL-C reduction of ≥50% after three months of treatment. Secondary outcomes include the frequency of adverse effects, adherence to therapy, and changes in liver function tests (LFTs) and creatine phosphokinase (CPK) levels. The study will contribute to understanding the role of moderate-intensity statins in managing LDL-C levels and guide future clinical practices for patient subgroups at risk of adverse effects from high-intensity therapy.
Interventions
DRUGModerate-Intensity Statins
Participants will be administered statins based on moderate intensity. This group will receive oral tablets once daily for 3 months. The intervention includes Atorvastatin 20 mg and rosuvastatin 10 mg.
DRUGHigh-Intensity Statins
Participants will be administered statins based on high intensity. This group will receive oral tablets once daily for 3 months. The intervention includes Atorvastatin 40 mg and rosuvastatin 20 mg.
Sponsors
Khyber Teaching Hospital
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Randomized (Blocked randomization)
Intervention model description
Patients are allocated into two groups by blocked randomization (6 blocks ensuring balanced allocation).
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged between 25 and 85 years. * Both males and females. * Diagnosed with acute coronary syndrome as defined in the operational definitions.
Exclusion criteria
* History of adverse reactions to statins (e.g., hypersensitivity, myopathy, acute renal failure). * Current acute liver disease. * Pregnant or breastfeeding women. * Participants already on statin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Low-Density Lipoprotein Cholesterol Level | 3 months after the start of treatment | The primary outcome is the percentage of participants achieving a reduction of ≥50% in LDL-C levels from baseline after 3 months of treatment with either moderate-intensity or high-intensity statins. LDL-C levels will be measured using lipid profiles obtained at baseline (upon admission) and at the end of the study (3 months post-treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Symptom Severity | Baseline and at 3 months | Reduction in the severity and frequency of symptoms, such as chest pain and fatigue, associated with acute coronary syndrome (ACS). Symptom severity will be measured using the Visual Analogue Scale (VAS) and patient-reported questionnaires. VAS scores for symptom severity: 1. 1-3 Mild pain 2. 2-6 Moderate pain 3. 7-10 Severe pain |
| Frequency of Elevated Creatine Phosphokinase (CPK) Levels | Throughout the 3-month | The number of participants with elevated CPK levels as an adverse effect of statin therapy, determined through laboratory tests. |
| Severity of Adverse Effects | Throughout the 3-month treatment duration | The severity of adverse effects, such as myopathy, elevated liver enzymes, and elevated CPK levels, categorized using predefined clinical severity scales. |
| Compliance with Statin Therapy | At 3 months | Evaluation of participant adherence to prescribed statin therapy, defined as the proportion of days with medication taken as prescribed over the 3-month period. Compliance will be assessed through patient questionnaires and medication logs. |
| Frequency of Myopathy | Throughout the 3-month treatment duration | The number of participants who develop myopathy as an adverse effect of statins, determined through clinical symptoms and laboratory tests. |
| Frequency of Elevated Liver Enzymes | Throughout the 3-month treatment duration | The number of participants with elevated liver enzyme levels (AST and ALT) as an adverse effect of statin therapy, determined through laboratory tests. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Liver Function Test (LFT) Results During Follow-Up | 1 month and 3 months | Changes in liver enzyme levels (AST and ALT) as measured through laboratory investigations at 1 month and 3 months. Unit of Measure: LFT levels (U/L) |
| Creatine Phosphokinase (CPK) Levels During Follow-Up | 1 month and 3 months | Changes in CPK levels as measured through laboratory investigations at 1 month and 3 months. Unit of Measure: CPK levels (U/L) |
| Lipid Profile Changes During Follow-Up | 1 month and 3 months | Changes in LDL-C levels as measured through laboratory investigations at 1 month and 3 months. Unit of Measure: LDL-C levels (mg/dL) |
Countries
Pakistan
Outcome results
None listed