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Completed

NCT Number: NCT01946815

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ulsan University Hospital, Ulsan, Gyeongsangbuk-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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

Primary outcomes

  1. changes of FFR between baseline and 12months follow-up

    Time frame: up to 1 year

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

Secondary outcomes

  1. Change of FFR according to the degree of decreased LDL

    Time frame: up to 1 year

    Change of FFR according to the degree of decreased LDL

  2. Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest

    Time frame: up to 1 year

    Change of % plaque volume, total atheroma volume & plaque compositions in lesion of interest

  3. Change of IMR

    Time frame: up to 1 year

    Change of IMR(index of microcirculatory resistance)

  4. Death including cardiac and noncardiac

    Time frame: up to 1 year

    Death including cardiac and noncardiac

  5. Myocardial infarction

    Time frame: up to 1 year

    Myocardial infarction

  6. Target lesion and vessel revascularization rate

    Time frame: up to 1 year

    Target lesion and vessel revascularization rate

  7. CVA: hemorrhage and infarction

    Time frame: up to 1 year

    CVA(cerebrovascular accident): hemorrhage and infarction

  8. side effect of statin : liver and muscle enzyme

    Time frame: up to 1 year

    side effect of statin : liver and muscle enzyme

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Collaborators

  • Inje University Ilsan Paik Hospital
  • Seoul National University Hospital
  • Ulsan University Hospital

Registry information

Official study title

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

Acronym: FORTE

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2013
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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