Back to resultsA 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)
Primary Purpose
Contrast-induced Acute Kidney Injury, ST Elevation Myocardial Infarction, Primary PCI
Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
hydration plus rosuvastatin therapy
Standard therapy
Sponsored by
About this trial
This is an interventional prevention trial for Contrast-induced Acute Kidney Injury
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
Sites / Locations
- The General Hospital of Shenyang Millitary Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hydration plus rosuvastatin therapy
Standard therapy
Arm Description
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.
No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The peak value of Scr
The rate of Aggravated Heart Function
Aggravated at Least 1 Class of Heart Function
The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration
the level of hsCRP
The Composite of all-cause death, MI, stroke, and TVR
Full Information
NCT ID
NCT03526367
First Posted
April 25, 2018
Last Updated
September 17, 2019
Sponsor
Shenyang Northern Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03526367
Brief Title
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
Acronym
TRACK-AMI
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn for no sufficient fund support.
Study Start Date
February 20, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Acute Kidney Injury, ST Elevation Myocardial Infarction, Primary PCI, Rosuvastatin, Hydration
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydration plus rosuvastatin therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.
Intervention Type
Drug
Intervention Name(s)
hydration plus rosuvastatin therapy
Intervention Description
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
Intervention Name(s)
Standard therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
CIAKI
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
The peak value of Scr
Time Frame
withtin 7 days before randomized
Title
The rate of Aggravated Heart Function
Description
Aggravated at Least 1 Class of Heart Function
Time Frame
withtin 30 days before randomized
Title
The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration
Time Frame
withtin 30 days before randomized
Title
the level of hsCRP
Time Frame
withtin 7 days before randomized
Title
The Composite of all-cause death, MI, stroke, and TVR
Time Frame
withtin 30 days before randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
The General Hospital of Shenyang Millitary Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital of Shenyang Millitary Region
City
Shenyang
State/Province
Liaoning
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
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