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

NCT03526367 | Withdrawn Phase 4 DMC

• 1 other identifier: TRACK-AMI V1.0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The peak value of Scr

  withtin 7 days before randomized

• The rate of Aggravated 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

Study Arms (2)

hydration plus rosuvastatin therapy

EXPERIMENTAL

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.

Drug: hydration plus rosuvastatin therapy

Standard therapy

ACTIVE COMPARATOR

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

Drug: Standard therapy

Interventions

hydration plus rosuvastatin therapy 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

hydration plus rosuvastatin therapy

Standard therapy 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.

Standard therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

The General Hospital of Shenyang Millitary Region

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yaling Han, MD

  The General Hospital of Shenyang Millitary Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 16, 2018
• Study Start: February 20, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CN (1)