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

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Atorvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Gyeongbuk
    • Ulsan, Gyeongbuk, Korea, Republic of
      • Ulsan University Hospital
  • Kyeongki
    • Ilsan, Kyeongki, Korea, Republic of
      • Inje University Ilsan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

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.	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.; Other Names: lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of FFR according to the degree of decreased LDL	Change of FFR according to the degree of decreased LDL	up to 1 year
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
Change of IMR	Change of IMR(index of microcirculatory resistance)	up to 1 year
Death including cardiac and noncardiac	Death including cardiac and noncardiac	up to 1 year
Myocardial infarction	Myocardial infarction	up to 1 year
Target lesion and vessel revascularization rate	Target lesion and vessel revascularization rate	up to 1 year
CVA: hemorrhage and infarction	CVA(cerebrovascular accident): hemorrhage and infarction	up to 1 year
side effect of statin : liver and muscle enzyme	side effect of statin : liver and muscle enzyme	up to 1 year

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Collaborators: Seoul National University Hospital; Ulsan University Hospital; Inje University Ilsan Paik Hospital
• Investigators: Principal Investigator: Chang-Wook Nam, Postdoctoral, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: November 1, 2018

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