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NCT Number: NCT06782243

Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate-Intensity Statins

Drug

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.

Other names: Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)

High-Intensity Statins

Drug

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.

Other names: Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)

Primary outcomes

  1. 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

  1. Frequency of Myopathy

    Time frame: 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.

  2. Frequency of Elevated Liver Enzymes

    Time frame: 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.

  3. Frequency of Elevated Creatine Phosphokinase (CPK) Levels

    Time frame: Throughout the 3-month

    The number of participants with elevated CPK levels as an adverse effect of statin therapy, determined through laboratory tests.

  4. Severity of Adverse Effects

    Time frame: 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.

  5. Compliance with Statin Therapy

    Time frame: 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.

  6. Reduction in Symptom Severity

    Time frame: 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:

    • 1-3 Mild pain
    • 2-6 Moderate pain
    • 7-10 Severe pain

Other outcomes

  1. Lipid Profile Changes During Follow-Up

    Time frame: 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)

  2. Liver Function Test (LFT) Results During Follow-Up

    Time frame: 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)

  3. Creatine Phosphokinase (CPK) Levels During Follow-Up

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Khyber Teaching Hospital

Registry information

Official study title

Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome: Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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