Phase 4 Study of Atorvastatin 10mg vs. 40mg in Follow-up CFR in AMI Patients
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) 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).
Inclusion Criteria:
Exclusion Criteria: