Status:
COMPLETED
Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
Lead Sponsor:
Shenyang Northern Hospital
Conditions:
Diabetes Mellitus
Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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％)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
2998 Patients enrolled
Trial Details
Trial ID
NCT00786136
Start Date
December 1 2008
End Date
November 1 2011
Last Update
April 10 2013
Active Locations (53)
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1
The Armed Police General Hospital
Beijing, Beijing Municipality, China, 100000
2
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Beijing, Beijing Municipality, China, 100000
3
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Beijing, Beijing Municipality, China, 100034
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