Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— FORTE  

Official title:

Phase 3 Study of Effect of ATorvastatin on Fractional Flow Reserve in Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946815
• Other study ID #: FORTE
• Status: Completed
• Phase: Phase 3
• Start date: September 2013
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin
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.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical center	Daegu
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan	Kyeongki
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan	Gyeongbuk

Sponsors (4)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Inje University Ilsan Paik Hospital, Seoul National University Hospital, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of FFR between baseline and 12months follow-up	changes of FFR(fractional flow reserve) baseline and 12month foloow-up	up to 1 year
Secondary	Change of FFR according to the degree of decreased LDL	Change of FFR according to the degree of decreased LDL	up to 1 year
Secondary	Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest	Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest	up to 1 year
Secondary	Change of IMR	Change of IMR(index of microcirculatory resistance)	up to 1 year
Secondary	Death including cardiac and noncardiac	Death including cardiac and noncardiac	up to 1 year
Secondary	Myocardial infarction	Myocardial infarction	up to 1 year
Secondary	Target lesion and vessel revascularization rate	Target lesion and vessel revascularization rate	up to 1 year
Secondary	CVA: hemorrhage and infarction	CVA(cerebrovascular accident): hemorrhage and infarction	up to 1 year
Secondary	side effect of statin : liver and muscle enzyme	side effect of statin : liver and muscle enzyme	up to 1 year