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 (TRACK-AMI)

Shenyang Northern Hospital

Status and phase: Withdrawn; Phase 4

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

Treatments: Drug: hydration plus rosuvastatin therapy; Drug: Standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03526367

TRACK-AMI V1.0

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

hydration plus rosuvastatin therapy

Experimental group

Description:

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.

Treatment:

Drug: hydration plus rosuvastatin therapy

Standard therapy

Active Comparator group

Description:

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

Treatment:

Drug: Standard therapy