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

NCT05306990 | Completed

• 1 other identifier: pharmacy practice department
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Diabetes Mellitus

Keywords

High intensity statin therapy; Acute coronary syndrome; Atorvastatin; Rosuvastatin; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

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

  A measure of participants with response

  Post intervention at week 12

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin tablets Dosage and frequency: 40mg orally once daily

Drug: Atorvastatin 40 Mg Oral Tablet

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin tablets Dosage and frequency: 20mg orally once daily

Drug: Rosuvastatin 20 Mg Oral Tablet

Interventions

Atorvastatin 40 Mg Oral Tablet DRUG

patients followed up for 3 months

Also known as: Ator

Atorvastatin

Rosuvastatin 20 Mg Oral Tablet DRUG

patients followed up for 3 months

Also known as: crestor

Rosuvastatin

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Heart Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus; Acute Coronary Syndrome

Interventions

Atorvastatin; Tablets; ORANGE protein, Arabidopsis; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at pharmacy practice department Faculty of pharmacy Helwan University

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: April 20, 2017
• Primary Completion: June 15, 2019
• Study Completion: January 31, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)