Rare Disease Trial, Recruiting (NCT07447648)

Rare Disease Trial, Recruiting NCT07447648 Sponsor: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) Condition: Rare Disease

Printed from Voxsanity (voxsanity.com.au) — NCT07447648 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You are willing and able to sign a consent form agreeing to share your health data, both past and future.
You are aged 12 or older (note: in Italy and France, you must be 18 or older).
You have been diagnosed with a condition called Homozygous Familial Hypercholesterolemia (HoFH) — a serious inherited condition causing very high cholesterol — either through genetic testing or clinical assessment.
For the intensified treatment group: you started a specific cholesterol-lowering medication called Evinacumab within the last 24 months, added on top of other cholesterol-lowering medicines you had been taking at a stable dose for at least 30 days beforehand.
For the standard treatment group: you are taking standard cholesterol-lowering medicines (such as statins, ezetimibe, and/or PCSK9 inhibitors) at a stable dose, and have had the required heart scan (CCTA) with a follow-up scan planned 18–24 months later.
You have had a specific type of heart imaging scan (called a CCTA) done around the time your treatment started, and a follow-up scan is available or planned 18–24 months later.
Your LDL ("bad") cholesterol is still 140 mg/dL (3.5 mmol/L) or higher, even while taking cholesterol-lowering treatment.

Who may not be able to join:

You have taken part in another clinical trial using an experimental drug within the last 6 months.
Your past medical records are not available or detailed enough for the study team to use.
You are unwilling or unable to give your consent to take part.
You have previously had bypass heart surgery on multiple blood vessels (having had single-vessel bypass surgery does not exclude you).
You have moderate to severe kidney disease, kidney failure, or are receiving ongoing kidney replacement treatment (such as dialysis) or have had a kidney transplant.
You were pregnant at the time your cholesterol-lowering treatment was given.
For the intensified group only: you are taking Evinacumab in a way that is not in line with its approved use (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07447648

Sponsor: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)

Phase: Not Applicable

Status: Recruiting

Condition: Rare Disease

More information: https://clinicaltrials.gov/study/NCT07447648

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are willing and able to sign a consent form agreeing to share your health data, both past and future.
You are aged 12 or older (note: in Italy and France, you must be 18 or older).
You have been diagnosed with a condition called Homozygous Familial Hypercholesterolemia (HoFH) — a serious inherited condition causing very high cholesterol — either through genetic testing or clinical assessment.
For the intensified treatment group: you started a specific cholesterol-lowering medication called Evinacumab within the last 24 months, added on top of other cholesterol-lowering medicines you had been taking at a stable dose for at least 30 days beforehand.
For the standard treatment group: you are taking standard cholesterol-lowering medicines (such as statins, ezetimibe, and/or PCSK9 inhibitors) at a stable dose, and have had the required heart scan (CCTA) with a follow-up scan planned 18–24 months later.
You have had a specific type of heart imaging scan (called a CCTA) done around the time your treatment started, and a follow-up scan is available or planned 18–24 months later.
Your LDL ("bad") cholesterol is still 140 mg/dL (3.5 mmol/L) or higher, even while taking cholesterol-lowering treatment.

Who may not be able to join:

You have taken part in another clinical trial using an experimental drug within the last 6 months.
Your past medical records are not available or detailed enough for the study team to use.
You are unwilling or unable to give your consent to take part.
You have previously had bypass heart surgery on multiple blood vessels (having had single-vessel bypass surgery does not exclude you).
You have moderate to severe kidney disease, kidney failure, or are receiving ongoing kidney replacement treatment (such as dialysis) or have had a kidney transplant.
You were pregnant at the time your cholesterol-lowering treatment was given.
For the intensified group only: you are taking Evinacumab in a way that is not in line with its approved use (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)

Registry

ClinicalTrials.gov

Start date

30 April 2026

Est. completion

1 September 2027

Where this trial is recruiting

🇫🇷 France 🇮🇹 Italy 🇳🇱 Netherlands Turkey (Türkiye)

Primary endpoints

Stabilization or regression of atherosclerotic coronary plaques as measured by CCTA in Evinacumab patients vs conventional ones

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov