Clinical trial NCT03526367: 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
Official title: A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention (TRACK-AMI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Contrast-induced Acute Kidney Injury
ST Elevation Myocardial Infarction
Primary PCI
Rosuvastatin
Hydration
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: CIAKI
timeFrame: 7 days
Secondary outcomes:
measure: The peak value of Scr
timeFrame: withtin 7 days before randomized
measure: The rate of Aggravated Heart Function
timeFrame: withtin 30 days before randomized
measure: The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration
timeFrame: withtin 30 days before randomized
measure: the level of hsCRP
timeFrame: withtin 7 days before randomized
measure: The Composite of all-cause death, MI, stroke, and TVR
timeFrame: withtin 30 days before randomized
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The General Hospital of Shenyang Millitary Region
state: Liaoning
Study officials:
affiliation: The General Hospital of Shenyang Millitary Region
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References: