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

NCT00536887 | Completed Phase 4 DMC

• 1 other identifier: CFR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  8 month follow-up

Secondary Outcomes (1)

• 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

  8 months follow-up

Interventions

atorvastatin DRUG

atorvastatin 10 mg versus 40 mg during the 8 months of follow-up

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20448126 DERIVED

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Soon Jun Hong, MD, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Sang Yup Lim, MD, PhD

  Korea University Anam Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: July 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 9, 2012

Record last verified: 2012-04

Locations

KR (1)