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Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading (RESIST-ACS)

This study is currently recruiting participants.
Verified December 2011 by The Korean Society of Circulation
Sponsor:
Information provided by (Responsible Party):
Bong-Ki Lee, The Korean Society of Circulation
ClinicalTrials.gov Identifier:
NCT01491256
First received: December 1, 2011
Last updated: December 11, 2011
Last verified: December 2011
History of Changes

December 1, 2011
December 11, 2011
February 2010
November 2011   (final data collection date for primary outcome measure)
Index of microcirculatory resistance (IMR) [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished.
Same as current
Complete list of historical versions of study NCT01491256 on ClinicalTrials.gov Archive Site
Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading
Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome

Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.

One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12~24 hours after PCI.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Pre-procedural High dose atorvastatin loading
    Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention
    Other Name: Lipitor (Pfizer)
  • Drug: No pre-procedural high-dose atorvastatin loading
    atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention
    Other Name: Lipitor (Pfizer)
  • Active Comparator: High dose Atorvastatin
    Arm of pre-procedural high dose atorvastatin loading
    Intervention: Drug: Pre-procedural High dose atorvastatin loading
  • Placebo Comparator: Control
    No pre-procedural high dose atorvastatin loading
    Intervention: Drug: No pre-procedural high-dose atorvastatin loading
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention

Exclusion Criteria:

  • ST elevation myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure with pulmonary edema
  • Severe left ventricular dysfunction (LVEF < 30%)
  • History of previous coronary revascularization therapy
  • chronic total coronary occlusion
  • 3 vessel disease
  • Target lesion at distal segments or branches
  • Ostial lesion
  • Excessive coronary calcification or thrombi
  • Elevated transaminase
  • Renal dysfunction (serum creatinine > 2.0mg/dL
  • History of myopathy
  • Contra-indication to anti-platelet therapy
  • Not indicated for percutaneous coronary intervention
  • Other co-morbidity with life expectancy less than 1 year
Both
18 Years to 85 Years
No
Contact: Bong-Ki Lee, MD, PhD +82-10-6373-9290 nicedr@nate.com
Korea, Republic of
 
NCT01491256
RESIST-ACS
Yes
Bong-Ki Lee, The Korean Society of Circulation
The Korean Society of Circulation
Not Provided
Principal Investigator: Bong-Ki Lee, MD, PhD KangWon National University Hospital
The Korean Society of Circulation
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP