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

NCT ID: NCT03526367

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2019-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

hydration plus rosuvastatin therapy

Intervention Type: DRUG

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

Standard therapy

No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaling Han, MD

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Shenyang Millitary Region

Locations

The General Hospital of Shenyang Millitary Region

Shenyang, Liaoning, China

Countries

China

Other Identifiers

TRACK-AMI V1.0

Identifier Type: -

Identifier Source: org_study_id