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)

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)

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.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • The General Hospital of Shenyang Millitary Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CIAKI	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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The peak value of Scr		withtin 7 days before randomized
The rate of Aggravated Heart Function	Aggravated at Least 1 Class of Heart Function	withtin 30 days before randomized
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

Collaborators and Investigators

• Sponsor: Shenyang Northern Hospital
• Investigators: Principal Investigator: Yaling Han, MD, The General Hospital of Shenyang Millitary Region

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Emergencies; Acute Kidney Injury; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: TRACK-AMI V1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No