Clinical trial NCT06782243: Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome
Official title: Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Low-Density Lipoprotein Cholesterol
Cardiovascular Diseases
Drug Therapy, Combination
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
Collaborators: name: Khyber Teaching Hospital
First posted: 2025-01-17
Enrollment: 190
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are allocated into two groups by blocked randomization (6 blocks ensuring balanced allocation).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Low-Density Lipoprotein Cholesterol Level
timeFrame: 3 months after the start of treatment
Secondary outcomes:
measure: Frequency of Myopathy
timeFrame: Throughout the 3-month treatment duration
measure: Frequency of Elevated Liver Enzymes
timeFrame: Throughout the 3-month treatment duration
measure: Frequency of Elevated Creatine Phosphokinase (CPK) Levels
timeFrame: Throughout the 3-month
measure: Severity of Adverse Effects
timeFrame: Throughout the 3-month treatment duration
measure: Compliance with Statin Therapy
timeFrame: At 3 months
measure: Reduction in Symptom Severity
timeFrame: Baseline and at 3 months
Other outcomes:
measure: Lipid Profile Changes During Follow-Up
timeFrame: 1 month and 3 months
measure: Liver Function Test (LFT) Results During Follow-Up
timeFrame: 1 month and 3 months
measure: Creatine Phosphokinase (CPK) Levels During Follow-Up
timeFrame: 1 month and 3 months
Locations:
city: Peshawar
country: Pakistan
facility: MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Teaching Hospital
name: Dr Shafeeq Mehmood, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Khyber Teaching Hospital
name: Muhammad Faheem Mehmood, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trial Unit, Khyber Medical University Peshawar
name: Syed Muhammad Shabbir Ali Naqvi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reiner Z. Statins in the primary prevention of cardiovascular disease. Nat Rev Cardiol. 2013 Aug;10(8):453-64. doi: 10.1038/nrcardio.2013.80. Epub 2013 Jun 4.
citation: Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
citation: LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. doi: 10.1056/NEJMoa050461. Epub 2005 Mar 8.
citation: Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.