Acute Myocardial InfarctionPhase 4NCT00536887
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
A Phase 4 study testing atorvastatin in people with Acute Myocardial Infarction, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- atorvastatin
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2005to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- 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).
- Conditions
- Acute Myocardial Infarction
- Being tested
- atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
atorvastatin 10 mg versus 40 mg during the 8 months of follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 8 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startJul 2005
- Primary completionJan 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
- Investigators
- Soon Jun Hong, MD, PhD, Principal investigator, Korea University Anam HospitalSang Yup Lim, MD, PhD, Study director, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536887
- Sponsor's protocol ID
- CFR
- Status last verified
- Apr 2012
- First submitted
- 27 Sep 2007
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20448126
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Atorvastatin 10mg vs. 40mg in Follow-up CFR in AMI Patients
- ClinicalTrials.gov ID
- NCT00536887
- Acronym / sponsor ID
- CFR
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatinatorvastatin 10 mg versus 40 mg during the 8 months of follow-up | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
- Derived from this study: PubMed 20448126Hong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soon Jun Hong, MD, PhD principal investigator
Korea University Anam Hospital
Sang Yup Lim, MD, PhD study director
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atorvastatin in people with Acute Myocardial Infarction, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.