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CompletedNCT05306990Updated Apr 1, 2022

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

An interventional study of Atorvastatin 40 Mg Oral Tablet and Rosuvastatin 20 Mg Oral Tablet in Hydroxymethylglutaryl-CoA Reductase Inhibitors and Diabetes Mellitus, sponsored by Helwan University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-01.

Sponsored by Helwan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Apr 2017, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Diabetes Mellitus

Keywords

  • High intensity statin therapy
  • Acute coronary syndrome
  • Atorvastatin
  • Rosuvastatin
  • Diabetes mellitus
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 108 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Helwan University is the lead sponsor of 69 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis with type 2 diabetes.
  • Previous history of acute coronary syndrome.
  • Abnormal baseline lipid profile.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    Atorvastatin

    Atorvastatin tablets Dosage and frequency: 40mg orally once daily

    Drug: Atorvastatin 40 Mg Oral Tablet

  • Active comparator
    Rosuvastatin

    Rosuvastatin tablets Dosage and frequency: 20mg orally once daily

    Drug: Rosuvastatin 20 Mg Oral Tablet

Interventions

  • DrugAtorvastatin 40 Mg Oral Tablet

    patients followed up for 3 months

    Also known as: Ator

  • DrugRosuvastatin 20 Mg Oral Tablet

    patients followed up for 3 months

    Also known as: crestor

06

What researchers measure

Primary outcomes

  1. Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

    A measure of participants with response

    Time frame: Post intervention at week 12

07

Study locations

1 site
  • Heart Institute
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05306990
Lead sponsor
Helwan University
Responsible party
Yassmin Genina (Teaching assistant at pharmacy practice department Faculty of pharmacy Helwan University, Helwan University) — Principal investigator
First posted
Apr 1, 2022
Start date
Apr 20, 2017
Primary completion
Jun 15, 2019
Completion
Jan 31, 2021
Last update
Apr 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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