Not Yet RecruitingNot Applicable

NON CANONICAL ACTIVATION OF BOOD COAGULATION

200 participantsStarted 2025-11

Plain-language summary

Cardiovascular diseases (CVD) are the major cause of mortality and morbidity worldwide and most of them are characterized by enhanced generation of active -thrombin (T) from the inactive Prothrombin zymogen (ProT), a reaction catalysed by factor Xa. CVD may be idiopathic, but also appear as the expression of thrombotic complications occurring with variable incidence and severity in different (apparently unrelated) diseases, such as for instance Type-2 Diabetes (T2D) , Chronic Kidney Disease (CKD), Inflammatory Bowel Disease (IBD) , Cancer , rheumatoid (RA) arthritis , autoimmune diseases such as the AntiPhospholipid Syndrome (APS), bacterial and viral infectious diseases, and amyloid-related diseases such as Alzheimer's disease, IgG light-chain amyloidosis and human transthyretin (hTTR) Senile Systemic Amyloidosis.This Project aims at combining different and complementary expertise with the general purpose of identifying new pathogenetic mechanisms for CVD and explored the possibility to devise novel and more effective therapeutic strategies.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Patients with carotid artery stenosis (CAS). One hundred patients with atheromatous carotid artery stenosis (CAS), admitted to the Unit of Vascular Surgery (RU-UniCATT) of Fondazione Policlinico Universitario A. Gemelli IRCCS for carotid endoarterectomy or stenting as per standard of care, will be enrolled. These patients will be divided into two cohorts composed of 50 patients each: 1) asymptomatic form of CAS (Cohort A) and 2) symptomatic CAS (Cohort B). In each cohort, T2DM and not diabetic patients will be enrolled with a 1:1 ratio. Patients on low-dose aspirin, statins, ACE inhibitors, metformin, pioglitazone, and sulfonylureas for DM patients. Exclusion Criteria:any hemorrhagic coagulopathy, familial hypercholesterolemia, liver cirrhosis, sepsis, recent (12 months) surgery, trauma, IMA, or ischemic stroke, age \<18 years old and inability to understand and sign the informed consent form.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determination of total plasma protein carbonyls and VWF content and distribution of VWF multimers in T2D plasma samples.

Timeframe: six months

Trial details

NCT IDNCT07242521

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-31

Contact for this trial

Tinelli Giovanni Prof. Giovanni Tinelli

+39 3474864020 giovanni.tinelli@unicatt..it

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