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

NCT06782243 | Completed DMC

• 1 other identifier: KMU/DIR/CTU/2024/013
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Low-Density Lipoprotein Cholesterol; Cardiovascular Diseases; Drug Therapy, Combination

Outcome Measures

Primary Outcomes (1)

• Reduction in Low-Density Lipoprotein Cholesterol Level

  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).

  3 months after the start of treatment

Secondary Outcomes (6)

• 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

Other Outcomes (3)

• Lipid Profile Changes During Follow-Up

  1 month and 3 months

• Liver Function Test (LFT) Results During Follow-Up

  1 month and 3 months

• Creatine Phosphokinase (CPK) Levels During Follow-Up

  1 month and 3 months

Study Arms (2)

Moderate-Intensity Statin Group

ACTIVE COMPARATOR

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

Drug: Moderate-Intensity Statins

High-Intensity Statin Group

ACTIVE COMPARATOR

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

Drug: High-Intensity Statins

Interventions

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.

Also known as: Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)

High-Intensity Statin Group

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.

Also known as: Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)

Moderate-Intensity Statin Group

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged between 25 and 85 years.
• Both males and females.
• Diagnosed with acute coronary syndrome as defined in the operational definitions.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Khyber Teaching Hospital: collaborator

Study Sites (1)

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

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 23736519 BACKGROUND

• 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.

  PMID: 15007110 BACKGROUND

• 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.

  PMID: 15755765 BACKGROUND

• 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.

  PMID: 21067804 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Cardiovascular Diseases

Interventions

Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Dr Shafeeq Mehmood, MBBS

  Khyber Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Muhammad Faheem Mehmood, MBBS

  Khyber Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Syed Muhammad Shabbir Ali Naqvi

  Clinical Trial Unit, Khyber Medical University Peshawar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized (Blocked randomization)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 17, 2025
• Study Start: December 20, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 25, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be made available starting six months after the publication of the study results and will remain accessible for a period of five years.
• Access Criteria: Access to the data will be granted upon approval of a written proposal outlining the purpose of the data request and intended use. Researchers must provide a signed data access agreement to ensure data confidentiality and compliance with ethical standards.

Locations

PA (1)