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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-08-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are allocated into two groups by blocked randomization (6 blocks ensuring balanced allocation).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Randomized (Blocked randomization)

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Moderate-Intensity Statins

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

High-Intensity Statins

Intervention Type 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.

Interventions

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High-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.

Intervention Type DRUG

Moderate-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.

Intervention Type DRUG

Other Intervention Names

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Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin) Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No