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
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Korea University Anam Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00536887
First Posted
September 27, 2007
Last Updated
April 6, 2012
Sponsor
Korea University Anam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00536887
Brief Title
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
Official Title
Phase 4 Study of Atorvastatin 10mg vs. 40mg in Follow-up CFR in AMI Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
atorvastatin 10 mg versus 40 mg during the 8 months of follow-up
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon Jun Hong, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Yup Lim, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20448126
Citation
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.
Results Reference
derived
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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
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