Effects of Atorvastatin 10 mg Versus 40 mg in Eight Months Follow-up Coronary Flow Reserve and Bone Marrow Stem Cell Mobilization in Patients With Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soon Jun Hong, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00536887
First received: September 27, 2007
Last updated: April 6, 2012
Last verified: April 2012

September 27, 2007
April 6, 2012
July 2005
January 2008   (final data collection date for primary outcome measure)
Comparison of atorvastatin 10 mg versus 40 mg on 8 months follow-up coronary flow reserve (CFR) and on the serial changes in stem cell mobilization (CD34, CD117, CD133, CXCR4+, C-met) after acute myocardial infarction. [ Time Frame: 8 month follow-up ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00536887 on ClinicalTrials.gov Archive Site
Comparison of atorvastatin 10 mg versus 40 mg on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin) and on the clinical events such as cardiac death, myocardial infarction, target vessel revascularization during the 8 mon [ Time Frame: 8 months follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Atorvastatin 10 mg Versus 40 mg in Eight Months Follow-up Coronary Flow Reserve and Bone Marrow Stem Cell Mobilization in Patients With Acute Myocardial Infarction
Phase 4 Study of Atorvastatin 10mg vs. 40mg in Follow-up CFR in AMI Patients

Many data indicate that statins increase mobilization of bone marrow-derived stem cells, and circulating bone marrow-derived stem cells are capable of homing to sites of myocardial infarction and endothelial disruption, thereby restoring myocardial function and microvascular integrity after acute myocardial infarction. Atorvastatin is widely used in the treatment of hyperlipidemia, especially after acute myocardial infarction. High-dose atorvastatin has been known to stop the progression of atherosclerosis and to decrease the levels of inflammatory markers.

The purpose of this prospective, randomized, single-blinded trial is to compare the effect of atorvastatin 10 mg versus 40 mg in restoring coronary flow reserve (CFR) and in serial bone marrow stem cell mobilization during the 8 months follow-up in patients with acute myocardial infarction.

Percutaneous coronary intervention is considered as the gold standard for primary treatment after acute myocardial infarction, and clinical outcome and recovery of myocardial contractility after successful coronary intervention are influenced by the extent of microvascular damage. The use of intracoronary Doppler evaluation of infarct-related coronary artery allows direct assessment of microvascular integrity after acute myocardial infarction. The assessment of coronary flow reserve should be performed at least 24 hours after acute myocardial infarction, and we will evaluate coronary flow reserve 5 days after acute myocardial infarction. Intracoronary Doppler wire will be placed just distal to the stent, and intracoronary Doppler assessment is repeated 8 months after coronary stenting at the same point.

  1. Primary end point: Comparison of atorvastatin 10 mg versus 40 mg on 8 months follow-up coronary flow reserve (CFR) and on the serial changes in stem cell mobilization (CD34, CD117, CD133, CXCR4+, C-met) after acute myocardial infarction.
  2. Secondary end point: Comparison of atorvastatin 10 mg versus 40 mg on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin) and on the clinical events such as cardiac death, myocardial infarction, target vessel revascularization during the 8 months of follow-up.

1) Study design

  • Prospective, randomized, single-blinded study.
  • Patients enrollment: 100 patients (50 patients in each group) considering 20% drop-out rate.
  • After informed consent, patients will be randomly assigned to the Atorvastatin 10 mg Group or the Atorvastatin 40 mg Group.

    2) Study protocol

  • After IRB approval, we will enroll within 10 months 100 acute myocardial infarction patients requiring stent implantation.
  • Study follow-up period will be 8 months.
  • Baseline clinical, laboratory, and angiographic parameters will be obtained at baseline and at 8 months follow-up. Out-patients follow-up will be scheduled at 4 weeks, 16 weeks, 32 weeks after sirolimus-eluting stent implantation.
  • We will compare atorvastatin 10 mg versus atorvastatin 40 mg on the changes in coronary flow reserve during the 8 months of follow-up. The serial changes (baseline, 24 hours, 48 hours, 5 days, 8 months) in stem cell mobilization (CD34, CD117, CD133, CXCR4+, C-met) will be compared in addition to major adverse cardiac events (cardiac death, myocardial infarction, target vessel revascularization) and inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Myocardial Infarction
Drug: atorvastatin
atorvastatin 10 mg versus 40 mg during the 8 months of follow-up
Not Provided
Hong SJ, Choi SC, Kim JS, Shim WJ, Park SM, Ahn CM, Park JH, Kim YH, Lim DS. Low-dose versus moderate-dose atorvastatin after acute myocardial infarction: 8-month effects on coronary flow reserve and angiogenic cell mobilisation. Heart. 2010 May;96(10):756-64. doi: 10.1136/hrt.2009.182683.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years and above
  • Gender eligible for study both
  • Patients with acute myocardial infarction requiring sirolimus-eluting stent implantation
  • Acute myocardial infarction affecting proximal to mid coronary arteries
  • No lesions greater than 50 percent diameter stenosis distal to the stent implantation
  • Patients with informed consent

Exclusion Criteria:

  • Left main lesion
  • Killip Class IV acute myocardial infarction
  • Patients with current use of any statin
  • Tortuous lesion with difficult intracoronary Doppler wiring
  • Acute myocardial infarction affecting distal coronary arteries
  • Acute myocardial infarction affecting branching coronary arteries
  • The use of thiazolidinediones within 3 months
  • Previous history of PCI or bypass surgery on infarct-related coronary artery
  • Patients with any contraindications to the treatment of atorvastatin
  • Pregnant or lactating patients
  • Chronic alcohol or drug abuse
  • Hepatic dysfunction (3 times above upper normal limit 5 days after AMI)
  • Renal dysfunction (Creatinine greater than 2.0 mg/dL)
  • Severe Heart failure (EF less than 25 percent)
  • Expected life expectancy of less thna 1 year
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00536887
CFR
Yes
Soon Jun Hong, Korea University Anam Hospital
Korea University Anam Hospital
Not Provided
Principal Investigator: Soon Jun Hong, MD, PhD Korea University Anam Hospital
Study Director: Sang Yup Lim, MD, PhD Korea University Anam Hospital
Korea University Anam Hospital
April 2012

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