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

Last updated: January 16, 2025
Sponsor: Khyber Medical University Peshawar
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Myocardial Ischemia

Chest Pain

Treatment

Moderate-Intensity Statins

High-Intensity Statins

Clinical Study ID

NCT06782243
KMU/DIR/CTU/2024/013
  • Ages 25-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • History of adverse reactions to statins (e.g., hypersensitivity, myopathy, acuterenal failure).

  • Current acute liver disease.

  • Pregnant or breastfeeding women.

  • Participants already on statin therapy

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Moderate-Intensity Statins
Phase:
Study Start date:
December 20, 2024
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

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

    Peshawar, Khyber Pakhtunkhwa 25000
    Pakistan

    Active - Recruiting

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