Effect of Atorvastatin on Fractional Flow Reserve in Coronary Artery Disease

NCT01946815 | Completed Phase 3

• 1 other identifier: FORTE
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  up to 1 year

• Change of IMR

  up to 1 year

• Death including cardiac and noncardiac

  up to 1 year

• Myocardial infarction

  up to 1 year

Study Arms (1)

Atorvastatin

EXPERIMENTAL

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

Interventions

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.

Also known as: lipitor

Atorvastatin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Seoul National University Hospital: collaborator
• Ulsan University Hospital: collaborator
• Inje University Ilsan Paik Hospital: collaborator

Study Sites (4)

Ulsan University Hospital

Ulsan, Gyeongsangbuk-do, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, Kyeongki, South Korea

Location

Keimyung University Dongsan Medical center

Daegu, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Lee CH, Hwang J, Kim IC, Cho YK, Park HS, Yoon HJ, Kim H, Han S, Hur SH, Kim KB, Kim JY, Chung JW, Lee JM, Doh JH, Shin ES, Koo BK, Nam CW. Effect of Atorvastatin on Serial Changes in Coronary Physiology and Plaque Parameters. JACC Asia. 2022 Nov 1;2(6):691-703. doi: 10.1016/j.jacasi.2022.07.010. eCollection 2022 Nov.

  PMID: 36444331 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Chang-Wook Nam, Postdoctoral

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 12, 2023

Record last verified: 2018-11

Locations

KR (4)