Hydroxymethylglutaryl-CoA Reductase InhibitorsNCT05306990
Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome
A study testing Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 20 Mg Oral Tablet in people with Hydroxymethylglutaryl-CoA Reductase Inhibitors and Diabetes Mellitus, run by Helwan University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diabetes Mellitus
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 20 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2017to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis with type 2 diabetes.
- Previous history of acute coronary syndrome.
- Abnormal baseline lipid profile.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial
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.
- Being tested
- Atorvastatin 40 Mg Oral Tablet, Rosuvastatin 20 Mg Oral Tablet
- Keywords
- High intensity statin therapy, Acute coronary syndrome, Atorvastatin, Rosuvastatin, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 Mg Oral TabletDrug
Also called Ator
patients followed up for 3 months
Rosuvastatin 20 Mg Oral TabletDrug
Also called crestor
patients followed up for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Atorvastatin tablets Dosage and frequency: 40mg orally once daily Receives: Drug: Atorvastatin 40 Mg Oral Tablet |
| Rosuvastatin | Active comparator | Rosuvastatin tablets Dosage and frequency: 20mg orally once daily Receives: Drug: Rosuvastatin 20 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
A measure of participants with response
Measured: Post intervention at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start20 Apr 2017
- Primary completion15 Jun 2019
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydroxymethylglutaryl-CoA Reductase InhibitorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin Genina, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306990
- Sponsor's protocol ID
- pharmacy practice department
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05306990
- Acronym / sponsor ID
- pharmacy practice department
- Keywords
- High intensity statin therapy, Acute coronary syndrome, Atorvastatin, Rosuvastatin, Diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin 40 Mg Oral TabletAtorvastatin tablets Dosage and frequency: 40mg orally once daily |
| Rosuvastatin | Active comparator | Drug: Rosuvastatin 20 Mg Oral TabletRosuvastatin tablets Dosage and frequency: 20mg orally once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis with type 2 diabetes.
- Previous history of acute coronary syndrome.
- Abnormal baseline lipid profile.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 40 Mg Oral TabletAlso: Atorpatients followed up for 3 months | Drug | Atorvastatin |
| Rosuvastatin 20 Mg Oral TabletAlso: crestorpatients followed up for 3 months | Drug | Rosuvastatin |
Primary outcome
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Post intervention at week 12
A measure of participants with response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 20 Mg Oral Tablet in people with Hydroxymethylglutaryl-CoA Reductase Inhibitors and Diabetes Mellitus, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) (time frame: Post intervention at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.