A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI

Phase 4

Withdrawn

• Conditions: Contrast-induced Acute Kidney Injury; ST Elevation Myocardial Infarction; Primary PCI; Rosuvastatin; Hydration
• Interventions: Drug: hydration plus rosuvastatin therapy; Drug: Standard therapy

• Registration Number: NCT03526367
• Lead Sponsor: Shenyang Northern Hospital

Brief Summary

The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Study Start: 2019-02-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18-80 years old
• The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
• The patients planned primary PCI;
• At least one of the following:

Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure

• Voluntary signature of informed consent

Exclusion Criteria

• Type 2 Myocardial infarction secondary to an ischaemic imbalance
• Intolerance of statin or iodine contrast
• eGFR<30ml/min
• Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment
• Hepatic dysfunction, ALT 3 times greater than upper normal limit
• Thyreoid insufficiency
• Hemodynamic instability
• Have received PCI or CABG within 30 day before enrollment
• Plan to perform any coronary angiography or PCI within 30 days
• Have received any statins within 7 days before enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydration plus rosuvastatin therapy	hydration plus rosuvastatin therapy	1. After randomized，hydration（3ml/kg/h, if patients had LVEF\<40%, 1.5 ml/kg/h）last 12 hours; 2. After randomized，a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days.
Standard therapy	Standard therapy	No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.

Primary Outcome Measures

Name	Time	Method
CIAKI	7 days	CIAKI, defined an Absolute Increase in SCr ≥0.5mg/dL（≥44.2μmmol/L）or a ≥ 25% Increase in SCr From Baseline to 7 days After the Procedure

Secondary Outcome Measures

Name	Time	Method
The peak value of Scr	withtin 7 days before randomized
The rate of Aggravated Heart Function	withtin 30 days before randomized	Aggravated at Least 1 Class of Heart Function
The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration	withtin 30 days before randomized
the level of hsCRP	withtin 7 days before randomized
The Composite of all-cause death, MI, stroke, and TVR	withtin 30 days before randomized

Trial Locations

Locations (1)

The General Hospital of Shenyang Millitary Region; 🇨🇳 Shenyang, Liaoning, China