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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

NCT03526367 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-09-19

No results posted yet for this study

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.

Conditions

  • Contrast-induced Acute Kidney Injury
  • ST Elevation Myocardial Infarction
  • Primary PCI
  • Rosuvastatin
  • Hydration

Interventions

DRUG

hydration plus rosuvastatin therapy

In experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized

DRUG

Standard therapy

Prohibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most.

Sponsors & Collaborators

  • Shenyang Northern Hospital

    lead OTHER

Principal Investigators

  • Yaling Han, MD · The General Hospital of Shenyang Millitary Region

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526367 on ClinicalTrials.gov