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

Shenyang Northern Hospital

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Diabetes Mellitus

Treatments: Drug: rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00786136

SYNH-20081028

Details and patient eligibility

About

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.

Enrollment: 2,998 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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％)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,998 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

perioperative rosuvastatin administration for at least 5 dosages

Treatment:

Drug: rosuvastatin

control

Placebo Comparator group

Description:

blank control of perioperative statin administration

Treatment:

Drug: rosuvastatin