Phase 4 Stroke Trial, Recruiting (NCT06212674)

Phase 4 Stroke Trial, Recruiting NCT06212674 Sponsor: Medical University of Silesia Condition: Stroke

Printed from Voxsanity (voxsanity.com.au) — NCT06212674 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Stroke

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 had an ischemic stroke (a stroke caused by a blood clot) between 2 and 12 weeks before joining the study, confirmed by a brain scan (CT or MRI), and your stroke symptoms lasted more than 24 hours
Your stroke caused mild to moderate physical or movement difficulties (not the most severe level of disability)
You have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF), either coming and going (paroxysmal) or ongoing (persistent), confirmed by a heart tracing (ECG) or heart monitor at any point before your screening appointment
Your risk score for stroke related to atrial fibrillation (called CHA2DS2-VA) is 2 or more points (confirm with trial site)
The shape and structure of your heart's left upper chamber is suitable for a specific heart procedure (confirm with trial site)
You have been taking blood thinning medication correctly for at least 4 weeks before joining
You are able and willing to have a heart ultrasound performed through your throat (called a TOE or TEE scan), with no medical reasons preventing this

Who may not be able to join:

You are currently taking part in another clinical trial
You are unwilling or unable to give written consent to participate
You are younger than 18 or older than 80 years of age
You have a mechanical heart valve, or had a biological mitral heart valve fitted within the last 3 months
You have had a blood clot in your leg or lungs (deep vein thrombosis or pulmonary embolism) in the last 6 months, or need long-term blood thinners for a reason unrelated to atrial fibrillation
You have a confirmed inherited or immune-related blood clotting disorder
Your kidneys are functioning at a very low level (eGFR of 15 or below) (confirm with trial site)
You have moderate or severe narrowing of the mitral heart valve caused by rheumatic disease
You have previously had a life-threatening bleed while on blood-thinning medication
Your stroke was caused by something other than atrial fibrillation
You have a type of atrial fibrillation linked to moderate or severe aortic heart valve disease caused by rheumatic disease
Your atrial fibrillation is permanent (constant and not able to be corrected)
Your atrial fibrillation has been continuous for more than one year
A scan has found a blood clot inside your heart's left upper chamber
Your stroke has left you with severe physical or movement difficulties (mRS score of 4–6 or NIHSS score of 16 or more)
You have had a major bleed in the 14 days before joining, or have ever had a bleed inside your skull
You currently have an overactive thyroid gland
You have had a heart attack within the last 90 days
You have previously had certain heart procedures, including a pulmonary vein isolation (PVI), a left atrial appendage closure (LAAO), or surgical closure of the left atrial appendage or a hole in the heart (ASD/PFO)
You have active or chronic inflammation around the heart (pericarditis or cardiac tamponade)
There is no suitable access point in your blood vessels for the required heart procedures
You have severe heart failure (NYHA Class IV) (confirm with trial site)
Your heart's pumping function is very low (ejection fraction below 30%)
You have advanced chronic kidney disease (eGFR below 30)
You have moderate or severe chronic liver failure
You have a severe heart valve problem
Your body mass index (BMI) is 40 or above
You are a woman of childbearing age who is planning to become pregnant, is currently pregnant, or is breastfeeding
Your life expectancy is estimated to be less than 4 years
You have active cancer, or have had cancer within the last 5 years and are not yet confirmed in remission
You currently have an active infection (such as a respiratory, urinary, or gut infection) with a raised inflammation marker in your blood (CRP above 30 mg/dL)

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 12 July 2026

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Maciej T. Wybraniec, MD, PhD, Professor, Medical University of Silesia

Phone: +48324796065

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

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: NCT06212674

Sponsor: Medical University of Silesia

Phase: Phase 4

Status: Recruiting

Condition: Stroke

Trial contact: +48324796065

More information: https://clinicaltrials.gov/study/NCT06212674

Eligibility summary (AI generated)

Written by an AI model from the 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 had an ischemic stroke (a stroke caused by a blood clot) between 2 and 12 weeks before joining the study, confirmed by a brain scan (CT or MRI), and your stroke symptoms lasted more than 24 hours
Your stroke caused mild to moderate physical or movement difficulties (not the most severe level of disability)
You have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF), either coming and going (paroxysmal) or ongoing (persistent), confirmed by a heart tracing (ECG) or heart monitor at any point before your screening appointment
Your risk score for stroke related to atrial fibrillation (called CHA2DS2-VA) is 2 or more points (confirm with trial site)
The shape and structure of your heart's left upper chamber is suitable for a specific heart procedure (confirm with trial site)
You have been taking blood thinning medication correctly for at least 4 weeks before joining
You are able and willing to have a heart ultrasound performed through your throat (called a TOE or TEE scan), with no medical reasons preventing this

Who may not be able to join:

You are currently taking part in another clinical trial
You are unwilling or unable to give written consent to participate
You are younger than 18 or older than 80 years of age
You have a mechanical heart valve, or had a biological mitral heart valve fitted within the last 3 months
You have had a blood clot in your leg or lungs (deep vein thrombosis or pulmonary embolism) in the last 6 months, or need long-term blood thinners for a reason unrelated to atrial fibrillation
You have a confirmed inherited or immune-related blood clotting disorder
Your kidneys are functioning at a very low level (eGFR of 15 or below) (confirm with trial site)
You have moderate or severe narrowing of the mitral heart valve caused by rheumatic disease
You have previously had a life-threatening bleed while on blood-thinning medication
Your stroke was caused by something other than atrial fibrillation
You have a type of atrial fibrillation linked to moderate or severe aortic heart valve disease caused by rheumatic disease
Your atrial fibrillation is permanent (constant and not able to be corrected)
Your atrial fibrillation has been continuous for more than one year
A scan has found a blood clot inside your heart's left upper chamber
Your stroke has left you with severe physical or movement difficulties (mRS score of 4–6 or NIHSS score of 16 or more)
You have had a major bleed in the 14 days before joining, or have ever had a bleed inside your skull
You currently have an overactive thyroid gland
You have had a heart attack within the last 90 days
You have previously had certain heart procedures, including a pulmonary vein isolation (PVI), a left atrial appendage closure (LAAO), or surgical closure of the left atrial appendage or a hole in the heart (ASD/PFO)
You have active or chronic inflammation around the heart (pericarditis or cardiac tamponade)
There is no suitable access point in your blood vessels for the required heart procedures
You have severe heart failure (NYHA Class IV) (confirm with trial site)
Your heart's pumping function is very low (ejection fraction below 30%)
You have advanced chronic kidney disease (eGFR below 30)
You have moderate or severe chronic liver failure
You have a severe heart valve problem
Your body mass index (BMI) is 40 or above
You are a woman of childbearing age who is planning to become pregnant, is currently pregnant, or is breastfeeding
Your life expectancy is estimated to be less than 4 years
You have active cancer, or have had cancer within the last 5 years and are not yet confirmed in remission
You currently have an active infection (such as a respiratory, urinary, or gut infection) with a raised inflammation marker in your blood (CRP above 30 mg/dL)

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 12 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

Phase 4

Sponsor

Medical University of Silesia

Registry

ClinicalTrials.gov

Start date

31 October 2025

Est. completion

31 October 2027

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

The rate of cardiovascular deaths, ischemic stroke, transient ischemic attack (TIA), systemic embolism or major bleeding unrelated to the procedure, including intracranial bleeding.

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: 12 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