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Completed

NCT Number: NCT05306990

Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome

The purpose of this study was to compare the efficacy and safety of high dose atorvastatin (40 mg) versus high dose rosuvastatin (20 mg) in Egyptian type II diabetic patients with previous acute coronary syndrome history. This open-labeled prospective, randomized clinical trial compared once daily atorvastatin 40mg (Ator®) versus once daily rosuvastatin 20mg (Crestor®). The primary outcome was the 50% reduction in low-density lipoprotein cholesterol levels at 12 weeks. The secondary outcome was the achievement of low-density lipoprotein cholesterol level < 55 mg/dl.

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Key information

Conditions

Hydroxymethylglutaryl-CoA Reductase Inhibitors Acute Coronary Syndrome Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis with type 2 diabetes.
  • Previous history of acute coronary syndrome.
  • Abnormal baseline lipid profile.

Exclusion criteria

  • Patients taking concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3.
  • Patients taking concurrent interacting medications such as ciclosporin, gemfibrozil, clarithromycin and/or itraconazole.
  • Patients with active liver disease, bile duct problems, or ALT > 3 × upper limit of normal (ULN).
  • Patients with serum creatinine > 2 mg/dl.
  • Patients have incidence or history of hypersensitivity reaction to any of the statin used.
  • Women who were pregnant, breast-feeding or of child-bearing potential and not using a reliable form of contraception at the time of recruitment

Treatment and study plan

Atorvastatin 40 Mg Oral Tablet

Drug

patients followed up for 3 months

Other names: Ator

Rosuvastatin 20 Mg Oral Tablet

Drug

patients followed up for 3 months

Other names: crestor

Primary outcomes

  1. Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Post intervention at week 12

    A measure of participants with response

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Apr 1, 2022
Registry last updated
Apr 1, 2022

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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