Status:
COMPLETED
Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome
Lead Sponsor:
Helwan University
Conditions:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 coron...
Eligibility Criteria
Inclusion
- Clinical diagnosis with type 2 diabetes.
- Previous history of acute coronary syndrome.
- Abnormal baseline lipid profile.
Exclusion
- 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
Key Trial Info
Start Date :
April 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05306990
Start Date
April 20 2017
End Date
January 31 2021
Last Update
April 1 2022
Active Locations (1)
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1
Heart Institute
Cairo, Egypt