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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Mohamed Abdelfatah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Statin group

Placebo group

Arm Description

100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention

100 patients received placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2020
Last Updated
February 15, 2022
Sponsor
Mohamed Abdelfatah
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1. Study Identification

Unique Protocol Identification Number
NCT04375787
Brief Title
Atorvastatin Effect on Contrast Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention
Official Title
High Dose Atorvastatin Raises Threshold of Contrast Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
June 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Abdelfatah

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: 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. (B) Methodology: All study patients were subjected to: 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. Thorough physical examination focusing on: General examination including intra-procedural hemodynamic assessment. Cardiac examination to elicit manifestations of heart failure. Echocardiography searching for wall motion abnormalities and estimation of left ventricular systolic function. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statin group
Arm Type
Active Comparator
Arm Description
100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
100 patients received placebo
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
statin
Intervention Description
Patients received 80 mg atorvastatin before elective coronary angiography
Primary Outcome Measure Information:
Title
Contrast Induced Nephropathy (CIN)
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 200 diabetic patients with indication for coronary intervention participated in the study Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Ibrahem, MD
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Abdel-Galeel, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24696755
Citation
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.
Results Reference
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PubMed Identifier
21943940
Citation
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.
Results Reference
background
PubMed Identifier
22714555
Citation
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.
Results Reference
background
PubMed Identifier
16949375
Citation
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.
Results Reference
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Atorvastatin Effect on Contrast Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention

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