Clinical trial NCT01946815: Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Official title: Phase 3 Study of Effect of ATorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Ulsan University Hospital
name: Inje University Ilsan Paik Hospital
First posted: 2013-09-20
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The patients who have intermediate CAD (30-80% diameter stenosis by visual estimation) with FFR≥0.80, or nonculprit coronary artery disease with FFR≥0.8 after culprit coronary artery disease intervention will be enrolled. FFR, IVUS(optional) and index of microcirculatory resistance (IMR) should be performed simultaneously. Atorvastatin 20mg is a starting dose, then up-titration will be done twice within each 4\~6weeks until LDL target goal (① LDL\<70mg/dl, or ② statin naive: \>50% reduction from baseline LDL, current statin user: \>30% reduction from baseline LDL). First titration will be atorvastatin 40mg, second will be atorvastatin 80mg. If patients have any adverse effect on atorvastatin, the dose of atorvastatin can be adjusted by investigator's decision. Official clinical follow-up except visit for statin dose titration will occur at 1, 12 months after index procedure. Follow-up coronary angiography, FFR,IMR,and IVUS(optional) will be performed 12 months after index procedure.

Eligibility criteria: 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

Primary outcomes:
measure: changes of FFR between baseline and 12months follow-up
timeFrame: up to 1 year
Secondary outcomes:
measure: Change of FFR according to the degree of decreased LDL
timeFrame: up to 1 year
measure: Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest
timeFrame: up to 1 year
measure: Change of IMR
timeFrame: up to 1 year
measure: Death including cardiac and noncardiac
timeFrame: up to 1 year
measure: Myocardial infarction
timeFrame: up to 1 year
measure: Target lesion and vessel revascularization rate
timeFrame: up to 1 year
measure: CVA: hemorrhage and infarction
timeFrame: up to 1 year
measure: side effect of statin : liver and muscle enzyme
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Gyeongbuk
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Kyeongki
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Chang-Wook Nam, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References: