Effect of Intensive cholesterol-lowering medication on blood flow in the coronary arteries in patients with coronary artery disease.

Phase 1

• Conditions: Patients with ischemic heart disease and significant, flow-limiting atherosclerosis in the coronary arteries; MedDRA version: 20.0Level: LLTClassification code 10055218Term: Ischemic heart diseaseSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001912-50-DK
• Lead Sponsor: Department of Cardiology, Aarhus University Hospital, Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-24
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed after 9 and 18 months.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Secondary endpoints will be assessed after 18 months.;Secondary end point(s): Secondary end-points are <br>1. ?FFRCT assessment after 9 months, <br>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), <br>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