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

NCT ID: NCT05306990

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2021-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin

Atorvastatin tablets Dosage and frequency: 40mg orally once daily

Group Type: ACTIVE_COMPARATOR

Atorvastatin 40 Mg Oral Tablet

Intervention Type: DRUG

patients followed up for 3 months

Rosuvastatin

Rosuvastatin tablets Dosage and frequency: 20mg orally once daily

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 20 Mg Oral Tablet

Intervention Type: DRUG

patients followed up for 3 months

Interventions

Atorvastatin 40 Mg Oral Tablet

patients followed up for 3 months

Intervention Type: DRUG

Rosuvastatin 20 Mg Oral Tablet

patients followed up for 3 months

Intervention Type: DRUG

Other Intervention Names

Ator; crestor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Yassmin Genina

Teaching assistant at pharmacy practice department Faculty of pharmacy Helwan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heart Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

pharmacy practice department

Identifier Type: -

Identifier Source: org_study_id