- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01946815
Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease (FORTE)
Phase 3 Study of Effect of ATorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Natural course of intermediate coronary artery disease (CAD) is very important to predict the prognosis of the patient with such disease.
Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the progression of CAD with the modification of lipid profiles.
This effect can be also explained by intravascular ultrasound (IVUS) or optical coherence tomography. However, the effect of plaque modification on coronary physiology has been rarely evaluated.
This research is to evaluate the change of intermediate or nonculprit coronary lesion on lipid-lowering therapy via IVUS(optional) and FFR.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Gyeongbuk
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Ulsan, Gyeongbuk, Korea, Republic of
- Ulsan University Hospital
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Kyeongki
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Ilsan, Kyeongki, Korea, Republic of
- Inje University Ilsan Paik Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patient > 18 years of age and willing to participate
- patients who have stable intermediate CAD(30-80% diameter stenosis by visual estimation) on angiography with FFR≥0.8,or who have nonculprit CAD which is not planned revascularization
- Signed written Informed Consent
Exclusion Criteria:
- Patients who are in cardiogenic shock
- Patients with LVEF<35%
- Patients with left main disease, restenotic, bypass grafted lesions
- Patients with platelet count < 100,000 cell/mm3
- Patients who have co-morbidity which reduces life expectancy to one year
- Patients who have a history of stroke or transient ischemic attack within 6 months
- Patients who are planned discontinuation of medication due to surgery
- Patients with known adverse reaction to HMG CO-A reductase therapy (statins)
- Patients with liver disease (elevation of AST or ALT more than 2 times)
- Patient with creatinine > 2.0 mg/dL
- Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
- Patients who consistently must take drugs affecting lipid levels in blood except the investigational product
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atorvastatin
Atorvastatin (Lipitor) will be prescribed with 20mg,40mg,or 80mg by the unit of 28 tablets upon the result of lipid profile.
Besides Clinical and lab test, follow-up CAG, IVUS(optional) and FFR will be performed in 12 months.
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Lipitor dose titration will be followed by the result of LDL lab test until it meets the target level of LDL.
IVUS(optional) and FFR during follow up CAG in 12 months will be measured to evaluate the effect of lipitor.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of FFR between baseline and 12months follow-up
Time Frame: up to 1 year
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changes of FFR(fractional flow reserve) baseline and 12month foloow-up
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up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of FFR according to the degree of decreased LDL
Time Frame: up to 1 year
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Change of FFR according to the degree of decreased LDL
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up to 1 year
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Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest
Time Frame: up to 1 year
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Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest
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up to 1 year
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Change of IMR
Time Frame: up to 1 year
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Change of IMR(index of microcirculatory resistance)
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up to 1 year
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Death including cardiac and noncardiac
Time Frame: up to 1 year
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Death including cardiac and noncardiac
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up to 1 year
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Myocardial infarction
Time Frame: up to 1 year
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Myocardial infarction
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up to 1 year
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Target lesion and vessel revascularization rate
Time Frame: up to 1 year
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Target lesion and vessel revascularization rate
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up to 1 year
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CVA: hemorrhage and infarction
Time Frame: up to 1 year
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CVA(cerebrovascular accident): hemorrhage and infarction
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up to 1 year
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side effect of statin : liver and muscle enzyme
Time Frame: up to 1 year
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side effect of statin : liver and muscle enzyme
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up to 1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chang-Wook Nam, Postdoctoral, Keimyung University Dongsan Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- FORTE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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