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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

November 5, 2008
April 9, 2013
December 2008
October 2011   (final data collection date for primary outcome measure)
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 ]
An absolute increase in SCr >=0.5mg/dL(>=44.2μmmol/L)from baseline to 72h after the procedure [ Time Frame: 72 h ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00786136 on ClinicalTrials.gov Archive Site
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 ]
  • a >= 25% increase in SCr [ Time Frame: 72 h ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Diabetes Mellitus
  • Chronic Kidney Disease
Drug: rosuvastatin
rosuvastatin
  • Experimental: 1
    perioperative rosuvastatin administration for at least 5 dosages
    Intervention: Drug: rosuvastatin
  • Placebo Comparator: control
    blank control of perioperative statin administration
    Intervention: Drug: rosuvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2998
November 2011
October 2011   (final data collection date for primary outcome measure)

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%)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00786136
SYNH-20081028
Yes
Han Yaling, MD, Shenyang Northern Hospital
Shenyang Northern Hospital
Not Provided
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital
Shenyang Northern Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP