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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306990
• Other study ID #: pharmacy practice department
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2022
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 31, 2021
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention

Drug:
• Atorvastatin 40 Mg Oral Tablet
patients followed up for 3 months
• Rosuvastatin 20 Mg Oral Tablet
patients followed up for 3 months

Locations

Country	Name	City	State
Egypt	Heart Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

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