Patients with ischemic heart disease and significant, flow-limiting atherosclerosis in the coronary arteries MedDRA version: 20.0 Level: LLT Classification code 10055218 Term: Ischemic heart disease System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Ezetimibe
Pharmaceutical Form: Tablet
INN or Proposed INN: EZETIMIBE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Atorvastatin
Pharm
Sponsors
Department of Cardiology, Aarhus University Hospital, Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: Patients must meet all of the following criteria: ? Age >40 years ?Symptoms suggestive of stable CAD ? No known CAD ? At least one stenosis with =50% lumen reduction determined by coronary CTA ? Sinus rhythm ? LDL cholesterol >2.0 mM* ? FFRCT =0.80 (Figure 2) ? Life expectancy >3 years ? Signed informed consent ? Minimum one stenosis =50% (visually or QCA). *Patients already on lipid lowering medical therapy can be included if meeting all of the above mentioned inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Patients must meet none of the following criteria: ? Unstable angina ? Known CAD ? BMI >40 ? Allergy to iodinated contrast media ? Poor coronary CTA image quality inadequate for FFRCT calculation (determined by core laboratory) ? Significant LM (stenosis >50%) or 3-vessel CAD determined by coronary CTA leading to direct referral to ICA (Figure 2) ? Pregnancy ? Participation in another clinical trial ? Does not wish to participate Coronary computed tomography exclusion criteria: LM- stenosis =50%, 3-VD or high-grade proximal LAD stenosis resulting in direct referral to ICA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate, whether two “18-months lipid lowering strategies” in stable CAD patients with fractional flow reserve (FFRCT) =0.80 is associated with regression of coronary adverse plaque characteristics and FFRCT recovery.;Secondary Objective: Non applicable;Primary end point(s): The primary endpoint will be the 18-month change in FFRCT (?FFRCT). ;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed after 9 and 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points are 1. ?FFRCT assessment after 9 months, 2. the temporal change in the number and volumes of coronary plaques (LDP volume, non-calcified and calcified plaque volumes, and the presence of positive remodeling), 3. temporal change in perivascular fat attenuation index, and 4. angina status, quality of life, and MACE (composite of all-cause death, myocardial infarction, unplanned revascularization or ICA) after 18 months ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be assessed after 18 months. | — |
Countries
Denmark
Contacts
Public ContactB-research
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
Outcome results
None listed