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

Not Applicable

Completed

• Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Diabetes Mellitus
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Rosuvastatin 20 Mg Oral Tablet

• Registration Number: NCT05306990
• Lead Sponsor: Helwan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Primary Completion: 2019-06-15
• Study Completion: 2021-01-31
• Status Verified: 2022-03
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin 40 Mg Oral Tablet	Atorvastatin tablets Dosage and frequency: 40mg orally once daily
Rosuvastatin	Rosuvastatin 20 Mg Oral Tablet	Rosuvastatin tablets Dosage and frequency: 20mg orally once daily

Primary Outcome Measures

Name	Time	Method
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)	Post intervention at week 12	A measure of participants with response

Trial Locations

Locations (1)

Heart Institute; 🇪🇬 Cairo, Egypt