Back to resultsStatins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome
Primary Purpose
Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin 40 Mg Oral Tablet
Rosuvastatin 20 Mg Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Hydroxymethylglutaryl-CoA Reductase Inhibitors focused on measuring High intensity statin therapy, Acute coronary syndrome, Atorvastatin, Rosuvastatin, Diabetes mellitus
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
Sites / Locations
- Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Atorvastatin
Rosuvastatin
Arm Description
Atorvastatin tablets Dosage and frequency: 40mg orally once daily
Rosuvastatin tablets Dosage and frequency: 20mg orally once daily
Outcomes
Primary Outcome Measures
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
A measure of participants with response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05306990
Brief Title
Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome
Official Title
Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diabetes Mellitus
Keywords
High intensity statin therapy, Acute coronary syndrome, Atorvastatin, Rosuvastatin, Diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Atorvastatin tablets Dosage and frequency: 40mg orally once daily
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Rosuvastatin tablets Dosage and frequency: 20mg orally once daily
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40 Mg Oral Tablet
Other Intervention Name(s)
Ator
Intervention Description
patients followed up for 3 months
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20 Mg Oral Tablet
Other Intervention Name(s)
crestor
Intervention Description
patients followed up for 3 months
Primary Outcome Measure Information:
Title
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Description
A measure of participants with response
Time Frame
Post intervention at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Heart Institute
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome
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