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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han Yaling, MD, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT00786136
First received: November 5, 2008
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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
rosuvastatin
Placebo Comparator: control
blank control of perioperative statin administration
 Drug: rosuvastatin
rosuvastatin

  Eligibility

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

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)
  • STEMI
  • 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％)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786136

  Show 53 Study Locations
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov 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
angiography

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Acute Kidney Injury
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
 Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013