Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)

This study has been completed.
Information provided by (Responsible Party):
Han Yaling, MD, Shenyang Northern Hospital Identifier:
First received: November 5, 2008
Last updated: April 9, 2013
Last verified: April 2013

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Condition Intervention Phase
Diabetes Mellitus
Chronic Kidney Disease
Drug: rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

Resource links provided by NLM:

Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • An absolute increase in SCr >=0.5mg/dL(>=44.2μmmol/L)or a >= 25% increase in SCr from baseline to 72h after the procedure [ Time Frame: 72 h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. [ Time Frame: 30 d ] [ Designated as safety issue: Yes ]

Enrollment: 2998
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
perioperative rosuvastatin administration for at least 5 dosages
Drug: rosuvastatin
Placebo Comparator: control
blank control of perioperative statin administration
Drug: rosuvastatin


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Planned diagnostic coronary or peripheral artery angiography
  • T2DM
  • CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
  • Statin naive, or not on statin treatment for at least 14 days
  • Withdrawal metformin or aminophylline for 48h before angiography
  • Total iodixanol volume

Exclusion Criteria:

  • Hypersensitivity to iodine-containing compounds and statins
  • Type 1 diabetes mellitus
  • Ketoacidosis
  • Lactic acidosis
  • CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
  • NYHA class IV or hemodynamic instability
  • Administration of any iodinated CM within 14 days before randomization
  • LDL-C<1.82mmol/L(70mg/dL)
  • Hepatic dysfunction (ALT 3 times greater than upper normal limit)
  • Thyreoid insufficiency
  • renal artery Stenosis(unilateral >70% or bilateral stenosis>50%)
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Please refer to this study by its identifier: NCT00786136

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Sponsors and Collaborators
Shenyang Northern Hospital
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Han Yaling, MD, vice president, Shenyang Northern Hospital Identifier: NCT00786136     History of Changes
Other Study ID Numbers: SYNH-20081028 
Study First Received: November 5, 2008
Last Updated: April 9, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
diabetes mellitus
chronic kidney disease
contrast induced acute kidney injury

Additional relevant MeSH terms:
Acute Kidney Injury
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Urologic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2016