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Rosuvastatin Prevent Contrast...

Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2998 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

perioperative rosuvastatin administration for at least 5 dosages

Group Type EXPERIMENTAL

rosuvastatin

Intervention Type DRUG

rosuvastatin

control

blank control of perioperative statin administration

Group Type PLACEBO_COMPARATOR

rosuvastatin

Intervention Type DRUG

rosuvastatin

Interventions

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rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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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％)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Han Yaling, MD

vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaling Han, MD

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

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