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

February 15, 2022 updated by: Mohamed Abdelfatah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.
  3. Echocardiography searching for wall motion abnormalities and estimation of left ventricular systolic function.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Statin group
100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention
Drug: Atorvastatin
Patients received 80 mg atorvastatin before elective coronary angiography
Other Names:
  • statin
PLACEBO_COMPARATOR: Placebo group
100 patients received placebo
Drug: Atorvastatin
Patients received 80 mg atorvastatin before elective coronary angiography
Other Names:
  • statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast Induced Nephropathy (CIN)
Time Frame: 48 hours
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Abdelfatah

Investigators

  • Study Chair: Ayman Ibrahem, MD, Assiut University
  • Study Director: Ahmed Abdel-Galeel, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2020

Primary Completion (ACTUAL)

June 2, 2020

Study Completion (ACTUAL)

June 2, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (ACTUAL)

May 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atorvastatin in elective CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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