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Coronary DiseasePhase 4NCT04375787

Atorvastatin Effect on Contrast Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention

A Phase 4 study testing Atorvastatin in people with Coronary Disease, run by Mohamed Abdelfatah at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigate of the potential benefit of acute pretreatment with high dose atorvastatin (80 mg) in reduction of the incidence of CIN in diabetic patients indicated for elective coronary intervention. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Coronary Disease
What is being tested?
Atorvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteEgypt
Study dates
15 Mar 2020to 2 Jun 2020
Phase
Phase 4
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 200 diabetic patients with indication for coronary intervention participated in the study

Who cannot join

  • Current statin treatment within the previous three months.
  • Chronic renal failure patients on renal dialysis, or serum creatinine more than 1.5 mg/dl.
  • Severe co-morbidities i.e. patients with cancer, advanced liver cirrhosis.
  • Contraindications to statin therapy.
  • Contrast media injection within the preceding 10 days.
  • Pregnancy.
  • Refusal of consent.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 71515

Other trials in Egypt

About this study

Official title: High Dose Atorvastatin Raises Threshold of Contrast Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention

Investigate of the potential benefit of acute pretreatment with high dose atorvastatin (80 mg) in reduction of the incidence of CIN in diabetic patients indicated for elective coronary intervention.

Read the detailed description

The study is a prospective, multi-center, randomized, placebo-controlled study. The ethical committee of the Faculty of Medicine, Assiut University approved the study protocol.

200 diabetic patients with indication for coronary intervention participated in the study. 100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention (statin group) and 100 patients received placebo (control group). An informed written consent for participating in the study was obtained from each participant.

Exclusion criteria:

  1. Current statin treatment within the previous three months.
  2. Chronic renal failure patients on renal dialysis, or serum creatinine more than 1.5 mg/dl.
  3. Severe co-morbidities i.e. patients with cancer, advanced liver cirrhosis.
  4. Contraindications to statin therapy.
  5. Contrast media injection within the preceding 10 days.
  6. Pregnancy.
  7. Refusal of consent. (B) Methodology:

All study patients were subjected to:

  1. Full clinical history: including age, sex, history of smoking, hypertension, history of previous percutaneous coronary intervention (PCI), duration of diabetes mellitus (DM) and type of anti-DM treatment.
  2. Thorough physical examination focusing on:
  • General examination including intra-procedural hemodynamic assessment.
  • Cardiac examination to elicit manifestations of heart failure.
  1. Echocardiography searching for wall motion abnormalities and estimation of left ventricular systolic function.
  2. Initial venous blood samples for determination of hemoglobin level and serum creatinine before the procedure. Follow up for serum creatinine at 48 hours post-procedure was done. CIN was stated as a raising of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from initial level within 48 hours of the angiographic procedure and after excluding other factors that may cause nephropathy such as nephrotoxic drugs.
  3. All patients received clopidogrel (600 mg) or ticagrelor (180 mg). Any nephrotoxic drugs (i.e., metformin, non-steroidal anti-inflammatory drugs) were withdrawn on admission.
  4. Coronary intervention was done using the same non-ionic, low-osmolar contrast medium (Iopamidol; Scanlux, Sanochemia, Austria) in all cases. After the procedure, TIMI flow of the culprit artery was assessed, as well as the volume of used contrast media and time of X-ray exposure.
  5. Statistical analysis:

Data were processed by statistical package for the social sciences (SPSS, version 20. 0). Descriptive statistics for interval and ordinal variables were calculated such as the ranges, means, and standard deviations, whereas, for categorical variables, the frequencies and percentages were reported. Student t-test or paired t-test, as appropriate, were used to compare normal and continuous variables. Chi-square test was used for comparing categorical variables. The level of significance was stated at P < 0.05. Receiver operating curves (ROC) were plotted and area under the curve (AUC) was assessed for some studied variables. Sensitivity and specificity were calculated at a cutoff point. A p value of <0.05 was considered significant.

Being tested
Atorvastatin
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called statin

    Patients received 80 mg atorvastatin before elective coronary angiography

Study groups in NCT04375787
Study groupRoleWhat they receive
Statin groupActive comparator100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention
Receives: Drug: Atorvastatin
Placebo groupPlacebo comparator100 patients received placebo
Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contrast Induced Nephropathy (CIN)

    CIN was defined as a rise of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours of the angiography

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start15 Mar 2020
  3. Primary completion2 Jun 2020
  4. Study completion2 Jun 2020

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
200 diabetic patients with indication for coronary intervention participated in the study. 100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention (statin group) and 100 patients received placebo (control group).
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04375787
Sponsor's protocol ID
Atorvastatin in elective CA
Status last verified
Feb 2022
First submitted
4 May 2020
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mohammed NM, Mahfouz A, Achkar K, Rafie IM, Hajar R. Contrast-induced Nephropathy. Heart Views. 2013 Jul;14(3):106-16. doi: 10.4103/1995-705X.125926.

    PubMed 24696755

  • Bolognese L, Falsini G, Schwenke C, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. Impact of iso-osmolar versus low-osmolar contrast agents on contrast-induced nephropathy and tissue reperfusion in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial). Am J Cardiol. 2012 Jan 1;109(1):67-74. doi: 10.1016/j.amjcard.2011.08.006. Epub 2011 Sep 22.

    PubMed 21943940

  • Perrin T, Descombes E, Cook S. Contrast-induced nephropathy in invasive cardiology. Swiss Med Wkly. 2012 Jun 19;142:w13608. doi: 10.4414/smw.2012.13608. eCollection 2012.

    PubMed 22714555

  • McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN Consensus Working Panel. Epidemiology and prognostic implications of contrast-induced nephropathy. Am J Cardiol. 2006 Sep 18;98(6A):5K-13K. doi: 10.1016/j.amjcard.2006.01.019. Epub 2006 Feb 10.

    PubMed 16949375

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin in people with Coronary Disease, run by Mohamed Abdelfatah 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 1 inclusion and 7 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 16 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contrast Induced Nephropathy (CIN) (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04375787, which also lists 4 linked publications.

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 16 Feb 2022.

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