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

Phase 4

Completed

• Conditions: Coronary Disease
• Interventions: Drug: Atorvastatin

• Registration Number: NCT04375787
• Lead Sponsor: Mohamed Abdelfatah

Brief 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.

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 Timeline

• Study Start: 2020-03-15
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Primary Completion: 2020-06-02
• Study Completion: 2020-06-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Atorvastatin	100 patients received placebo
Statin group	Atorvastatin	100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention

Primary Outcome Measures

Name	Time	Method
Contrast Induced Nephropathy (CIN)	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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt