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

NCT04375787 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Atorvastatin in elective CA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (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

  48 hours

Study Arms (2)

Statin group

ACTIVE COMPARATOR

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

Drug: Atorvastatin

Placebo group

PLACEBO COMPARATOR

100 patients received placebo

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Patients received 80 mg atorvastatin before elective coronary angiography

Also known as: statin

Placebo group; Statin group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Abdelfatah: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (4)

• 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.

  PMID: 24696755 BACKGROUND

• 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.

  PMID: 21943940 BACKGROUND

• 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.

  PMID: 22714555 BACKGROUND

• 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.

  PMID: 16949375 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Interventions

Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Ayman Ibrahem, MD

  Assiut University

  STUDY CHAIR

• Ahmed Abdel-Galeel, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 5, 2020
• Study Start: March 15, 2020
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)