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Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease (FORTE)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan University Hospital
  • Inje University Ilsan Paik Hospital
  • Keimyung University Dongsan Medical center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvastatin

Arm Description

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.

Outcomes

Primary Outcome Measures

changes of FFR between baseline and 12months follow-up
changes of FFR(fractional flow reserve) baseline and 12month foloow-up

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2013
Last Updated
April 11, 2023
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Seoul National University Hospital, Ulsan University Hospital, Inje University Ilsan Paik Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01946815
Brief Title
Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Acronym
FORTE
Official Title
Phase 3 Study of Effect of ATorvastatin on Fractional Flow Reserve in Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Seoul National University Hospital, Ulsan University Hospital, Inje University Ilsan Paik Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Wook Nam, Postdoctoral
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Gyeongbuk
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Kyeongki
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical center
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease

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