Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Reduction in Low-Density Lipoprotein Cholesterol Level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Randomized (Blocked randomization)
Eligibility Criteria
- Ages
- 25 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Moderate-Intensity Statin Group
Participants in this group will receive moderate-intensity statins (Atorvastatin 20 mg, Rosuvastatin 10 mg). The dosage will be in the tablet form, which will be Dosage Form: Tablet Frequency: Once daily Duration: 3 months
Intervention: Moderate-Intensity Statins (Drug)
High-Intensity Statin Group
Participants in this group will receive high-intensity statins. Interventions include Atorvastatin 40 mg, or Rosuvastatin 20 mg which will be taken in tablet form.
Frequency: Once daily Duration: 3 months
Intervention: High-Intensity Statins (Drug)
Outcomes
Primary Outcomes
Reduction in Low-Density Lipoprotein Cholesterol Level
Time Frame: 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 Outcomes
- Frequency of Myopathy(Throughout the 3-month treatment duration)
- Frequency of Elevated Liver Enzymes(Throughout the 3-month treatment duration)
- Frequency of Elevated Creatine Phosphokinase (CPK) Levels(Throughout the 3-month)
- Severity of Adverse Effects(Throughout the 3-month treatment duration)
- Compliance with Statin Therapy(At 3 months)
- Reduction in Symptom Severity(Baseline and at 3 months)