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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05306990

Enrollment

108

Registered

2022-04-01

Start date

2017-04-20

Completion date

2021-01-31

Last updated

2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diabetes Mellitus

Keywords

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

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.

Interventions

DRUGAtorvastatin 40 Mg Oral Tablet

patients followed up for 3 months

DRUGRosuvastatin 20 Mg Oral Tablet

patients followed up for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026