Influence of Lipid Lowering on Impaired Coronary Flow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2024-04-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)

NCT04737408

Coronary Artery Disease

UNKNOWN PHASE3

Ezetimibe and Atorvastatin Therapy on TCFA

NCT02588235

Coronary Artery Disease

UNKNOWN PHASE4

Effects of Ezetimibe Add-On to Statin Therapy on Adipokine Production in Obese and Metabolic Syndrome Patients With Atherosclerosis

NCT00485121

Metabolic Syndrome Obesity Coronary Artery Disease

COMPLETED NA

Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography

NCT06863545

Coronary Artery Disease CT Angiography PCSK9 +1 more

RECRUITING NA

A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173)

NCT03882905

Primary Hypercholesterolemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol \>2 mM), and at least one translesional FFRct value \<0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

usual care lipid lowering

Usual care: atorvastatin 40 mg

Group Type ACTIVE_COMPARATOR

High intensity lipid lowering

Intervention Type DRUG

Two different regimens of drugs with different effects on LDL lowering

Intensive lipid lowering

Intensive: rosuvastatin 40 mg + ezetimibe 10 mg

Group Type EXPERIMENTAL

High intensity lipid lowering

Intervention Type DRUG

Two different regimens of drugs with different effects on LDL lowering

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High intensity lipid lowering

Two different regimens of drugs with different effects on LDL lowering

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Usual care lipid lowering

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥35 y
* Symptoms suggestive of stable CAD
* No pre-CTA known CAD
* At least one lesion with FFRct \<0.81
* Sinus rhythm
* LDL cholesterol \>2.0 mM
* Statin use \>2 months
* Life expentancy \< 3 years
* Signed informed consent

Exclusion Criteria

* Known CAD
* Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
* Significant CAD in the left main or proximal coronary segments
* Referral to invasive catheterization
* Statin intolerance
* BMI \>40
* Allergy to ionidated contrast
* Pregnancy

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No