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Ischaemic stroke – Trials in Disease

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Clinical Trials for Ischaemic Stroke: Current Research and Treatment Options

There are currently 40 ongoing clinical trials investigating new treatments and therapies for ischaemic stroke. These studies are examining various approaches including medications, medical devices, and procedures aimed at improving outcomes for stroke patients. The trials are being conducted across multiple countries in Europe and beyond, offering opportunities for patients to participate in cutting-edge research.

Clinical trial locations

Comparison of General Anesthesia versus High-Flow Nasal Cannula Sedation in Patients with Acute Ischemic Stroke Undergoing Endovascular Treatment

This trial is comparing two different approaches to managing patients during mechanical thrombectomy, a procedure that removes blood clots from brain vessels. Patients eligible for this study must be between 18 and 85 years old and have had an acute stroke with a severity score (NIHSS) of 6 to 25 points. The stroke must be confirmed by brain imaging and must involve blockage in specific major blood vessels in the brain.

The main inclusion criteria include having a stroke affecting the front part of the brain, arriving at the hospital within specific time windows (either within 6 hours of symptom onset or within 24 hours if brain scans show salvageable tissue), and being able to provide informed consent either personally or through a legal representative.

Exclusion criteria include being outside the specified age range, having severe breathing problems, known allergies to anesthetic medications, recent stroke within the past 3 months, uncontrolled high blood pressure, active bleeding, extreme blood sugar levels, pregnancy or breastfeeding, severe heart problems, inability to provide consent, participation in another trial within 30 days, current treatment with blood thinners that cannot be reversed, signs of brain bleeding on initial scans, life expectancy less than 6 months, or history of severe reactions to contrast dye.

The study compares general anesthesia (which puts patients into deep sleep using medications like propofol, fentanyl, lidocaine, and rocuronium) versus high-flow nasal cannula sedation (which delivers oxygen through the nose while keeping patients conscious). The goal is to determine which approach leads to faster treatment times from hospital arrival to blood flow restoration in the brain.

Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

This study examines whether allopurinol, a medication that lowers uric acid levels in the blood, can help prevent serious cardiovascular events in patients with high cardiovascular risk, including those with long-COVID syndrome. Participants must be between 40 and 70 years old and have blood uric acid levels above 5mg/dl based on tests from the last 6 months.

The main inclusion criteria require meeting at least one high cardiovascular risk condition, such as having a calculated 10-year risk of death from heart disease above certain thresholds, documented history of stroke, heart failure, poor blood flow to legs, irregular heartbeat, or having diabetes or high blood pressure with organ damage showing as stiff blood vessels, enlarged heart muscle, increased protein in urine, or poor blood flow to ankles.

Exclusion criteria include current treatment with allopurinol or other uric acid-lowering medications, known allergy to allopurinol, severe kidney or liver disease, active cancer or ongoing cancer treatment, pregnancy or planning pregnancy, breastfeeding, participation in other trials within 30 days, history of serious allergic reactions to medications, inability to provide informed consent, life expectancy less than 12 months, severe mental illness, alcohol or drug dependency, recent major surgery (within 3 months), or unstable medical conditions requiring frequent medication changes.

The trial investigates whether allopurinol can improve cardiovascular outcomes by lowering uric acid levels and potentially protecting the heart and blood vessels. Participants will be monitored through regular health checks including heart examinations, blood vessel assessments, blood tests, blood pressure measurements, and heart rhythm checks throughout the study period, which continues until May 2028.

Study of Cerebrolysin to improve arm function in patients recovering from ischemic stroke

This trial evaluates whether Cerebrolysin, a neuropeptide preparation, can help improve arm function in patients recovering from acute ischemic stroke. Eligible participants must be between 18 and 80 years old and have experienced a stroke within the last 72 hours, confirmed by CT or MRI scans showing a stroke-affected area larger than 4 cubic centimeters.

The main inclusion criteria require that the affected arm scores less than 50 points on the ARAT test (which measures arm and hand function), participants score higher than 2 points on the Goodglass-Kaplan test (evaluating language and communication abilities), were fully independent or had minimal symptoms before the stroke (modified Rankin Scale score of 0 or 1), have not had another stroke with symptoms in the 3 months before this stroke, can understand study procedures, are willing to provide written informed consent, and are eligible to receive standard stroke treatment according to national guidelines.

Exclusion criteria include previous stroke episodes, severe heart conditions, uncontrolled high blood pressure, active infection or severe inflammatory conditions, current participation in other clinical trials, history of severe allergic reactions to medications, severe kidney or liver problems, pregnancy or breastfeeding, inability to follow study instructions or attend follow-up visits, major psychiatric disorders, use of medications that could interact with the study treatment, severe cognitive impairment, blood clotting disorders, terminal illness with life expectancy less than 90 days, or history of drug or alcohol abuse within the past 6 months.

The investigational drug Cerebrolysin is administered through infusion over 21 days alongside standard stroke treatment. The study measures recovery using various assessments at 90 days, including the Action Research Arm Test, NIH Stroke Scale, modified Rankin Scale, Barthel Index, Hospital Anxiety and Depression Scale, and quality of life questionnaire.

Study on Blood Pressure Management with Urapidil, Phenylephrine, and Labetalol for Patients with Acute Ischemic Stroke After Endovascular Therapy

This trial compares different approaches to blood pressure management after mechanical thrombectomy, a procedure to remove blood clots from large blood vessels in the brain. Participants must have acute ischemic stroke with successful blood flow restoration (TICI score of 2b, 2c, or 3) and a prior modified Rankin Scale score of 0, 1, or 2 before the stroke.

The main inclusion criteria require participants to have had an acute ischemic stroke caused by large vessel blockage confirmed by specific imaging tests, undergo mechanical thrombectomy, achieve successful blood vessel reopening as measured by TICI score, provide consent in writing or verbally, and have no clear need for other specific stroke treatments.

Exclusion criteria are not extensively detailed in the provided information but would typically include medical conditions other than acute ischemic stroke, being outside the specified age range, being part of a vulnerable population, not meeting specific health criteria set by the study, having had certain medical procedures or treatments incompatible with study requirements, or being unable to follow the study protocol or attend required visits.

The study uses three medications: Urapidil (which lowers blood pressure by relaxing blood vessels), Phenylephrine Hydrochloride (a cardiac stimulant that helps increase blood pressure), and Labetalol Hydrochloride (which works by blocking certain receptors in the body to lower blood pressure). Some participants may receive a placebo. The study aims to determine which blood pressure management method provides the most benefit to patients after stroke, with assessment of outcomes at 90 days after treatment using the modified Rankin Scale.

Study on Brain Inflammation in Stroke Patients Using Ficolin-2, Gadoteric Acid, and 18F-DPA-714

This study investigates the relationship between ficolin-2 levels in the blood and inflammation in the brain and carotid arteries in patients who have experienced stroke or transient ischemic attack. Participants must be 18 years or older and must have experienced a probable transient ischemic attack or ischemic stroke within 24 hours, with atherosclerotic carotid stenosis between 50% and 99% confirmed by imaging tests.

The main inclusion criteria require patients to provide signed written informed consent before any study-specific procedures and have confirmation of carotid artery narrowing through Doppler ultrasound, MR angiography, CT angiography, or catheter angiography after the stroke or TIA.

Exclusion criteria include patients who have had a stroke or transient ischemic attack (though this appears to be an error in the source data, as the trial specifically targets stroke and TIA patients).

The study uses 18F-DPA-714, a special imaging agent that helps doctors see inflammation in the brain and carotid arteries using PET/MRI scans. Participants undergo imaging on day 5 of the trial, with blood samples taken to measure ficolin-2 levels. Additional assessments are conducted on day 15. The research aims to explore how ficolin-2 levels relate to inflammation detected by advanced imaging techniques, potentially helping to identify or manage inflammation related to strokes.

Study on Colchicine and Ticagrelor for Preventing Ischemic Stroke in Patients with Atherosclerosis

This trial examines whether low doses of Colchicine and Ticagrelor can reduce the risk of recurrent major vascular events such as stroke or heart attack in patients who have experienced an ischemic stroke or have conditions like atherosclerosis. Participants must be 18 years or older and have a Rankin score of less than 4, meaning they can manage most daily activities with some help.

The main inclusion criteria require participants to have had a cerebral infarction confirmed by brain imaging tests (MRI or CT scans), have a medical check-up before joining, use effective birth control if capable of having children (with women taking a pregnancy test), have documented atherosclerotic stenosis in certain arteries confirmed by specific imaging tests or have a history of coronary artery disease, or have had a transient ischemic attack lasting 10 minutes or more with full recovery and no brain damage on imaging tests. Participants must not have a clear need for colchicine treatment, should need long-term antiplatelet therapy, must fully understand and sign a consent form, and must have a social security number.

Exclusion criteria include patients with a history of stroke, ischemic conditions, TIA, cardiac disease, atherosclerosis, myocardial infarction (heart attack), coronary syndrome, or cerebral infarction.

The study investigates Colchicine (used to reduce inflammation) at low doses and Ticagrelor (which helps prevent blood clots) at 90 mg twice daily. The treatment continues for 36 to 60 months with regular monitoring to assess effectiveness in preventing major vascular events, checking for recurrent strokes, heart attacks, or other vascular events, as well as assessing quality of life and cognitive function at regular intervals including 3, 6, 12, 18, and 24 months, with additional follow-up for those who join early.

Study on Intra-Arterial Thrombolysis with Alteplase for Patients with Acute Ischemic Stroke in the Anterior Circulation

This study evaluates whether adding intra-arterial thrombolysis (delivering medication directly into the arteries) can improve recovery outcomes for patients who have already had successful initial treatment for stroke. Participants must have a pre-stroke modified Rankin Scale score of 0-2, have experienced an acute ischemic stroke with blockage in the anterior circulation, and have an NIHSS score of 5 or higher at admission.

The main inclusion criteria require successful blood flow restoration confirmed through a catheter angiogram showing eTICI scores of 2b, 2c, or 3 after initial treatments, being between 18 and 85 years of age, and including both male and female patients. The study may include vulnerable populations who might need special protection or consideration.

Exclusion criteria include patients who have not experienced an ischemic stroke, do not have acute anterior circulation LVO stroke (blockage in a large blood vessel in the front part of the brain), have not achieved successful blood flow restoration after treatment, are not within the specified age range, are not part of the specified clinical trial groups, are not male or female, or are not considered part of a vulnerable population.

The investigational treatment uses intra-arterial thrombolysis with alteplase (Actilyse), delivered directly into the arteries. Participants are monitored for early neurological improvement within 24 hours, with follow-up assessments at various intervals including 24 hours, 36 hours, and 90 days post-treatment to evaluate functional outcomes using the modified Rankin Scale, along with additional assessments for any complications or overall recovery.

Study on JX10 for Improving Outcomes in Patients with Acute Ischemic Stroke

This international trial tests whether JX10 can improve recovery and reduce symptoms in patients who have had acute ischemic stroke. Participants must be between 18 and 90 years old and have experienced an acute ischemic stroke confirmed by CT Angiography or Magnetic Resonance Angiography showing blockage in blood vessels.

The main inclusion criteria require evidence of salvageable brain tissue shown by specific imaging tests, ability to start study treatment within 4.5 to 6 hours after stroke if no imaging is done (or within 4.5 to 24 hours if imaging shows salvageable tissue), initial stroke severity score (NIHSS) of 5 or higher, having been functionally independent before the stroke, and for women of childbearing potential, having a negative pregnancy test and using effective birth control during the study and for 30 days after the last dose. Men must use effective birth control during the study and for 90 days after the last dose and should not donate sperm during this time.

Exclusion criteria include recent head injury or brain surgery, history of bleeding disorders, current use of blood thinners, severe liver or kidney disease, major surgery in the last 30 days, uncontrolled high blood pressure, pregnancy or breastfeeding, known allergy to the study medication or its ingredients, participation in another clinical trial in the last 30 days, or serious infection.

The study medication JX10 is administered as an intravenous infusion within 6 hours of stroke onset. Participants are monitored for neurological improvement using the NIHSS at 24 hours, 72 hours, and 7 days, with a final evaluation at 90 days measuring disability level using the modified Rankin Scale, ability to perform daily activities using the Barthel Index, and cognitive function through telephone assessment.

Study on Mechanical Thrombectomy and Acetylsalicylic Acid for Patients with Acute Ischemic Stroke from Large Vessel Blockage

This trial explores whether combining mechanical thrombectomy (a procedure to physically remove blood clots) with standard treatment is more effective than standard treatment alone in improving patient outcomes. Participants must be adults with acute ischemic stroke caused by large vessel blockage, confirmed by specific imaging tests.

The main inclusion criteria require providing informed consent (if unable to sign due to severe symptoms, verbal consent with an independent witness is acceptable), having a DWI-FLAIR mismatch (a specific pattern on brain scans), having a neurological deficit scored between 5 and 18 on the NIHSS scale, being over 18 years old, and meeting specific timing criteria. For Arm A patients, the time when stroke symptoms started must be unknown but less than 24 hours since last symptom-free, or symptom onset to treatment must be between 6 and 24 hours, and they must not meet criteria for other specific stroke studies. For Arm B patients, they must have a score from 0 to 5 on the ASPECTS scale and the time from first stroke symptoms to treatment must not exceed 6 hours.

Exclusion criteria include recent bleeding in the brain, severe allergy to study medications, major surgery within the last 14 days, severe heart problems that are not stable, current participation in another clinical trial, serious infection that is not controlled, pregnancy or breastfeeding, unmanaged blood clotting disorder, stroke in the past 3 months, or severe liver or kidney disease.

The study uses Acetylsalicylic Acid (aspirin) to prevent blood clots and Mechanical Thrombectomy to physically remove the blood clot. Participants are randomly assigned to receive either standard treatment with acetylsalicylic acid alone or standard treatment plus mechanical thrombectomy, with follow-up assessments at 24 hours, 48 hours, 7 days, and 90 days to evaluate neurological function, quality of life, and imaging test results.

Study on Norepinephrine for Improving Outcomes in Patients with Acute Progressive Stroke

This study tests whether administering norepinephrine can improve recovery and functional independence for patients experiencing neurological deterioration during the acute phase of ischemic stroke. Participants must have had an acute ischemic stroke within 72 hours, be experiencing early neurological deterioration, and be at least 18 years old.

The main inclusion criteria require having an acute ischemic stroke in a specific area of the brain within the last 72 hours, showing early signs of worsening neurological condition confirmed by a neurologist (defined by an increase of 3 or more points in overall NIHSS score or a 2-point increase in movement or coordination scores), having less than 6 hours between the early worsening and the start of the trial, being 18 years or older, women of childbearing potential using contraception, and being covered by a health insurance system.

Exclusion criteria include patients who have had a recent stroke, are not within the specified age range, are unable to give consent, have other serious health conditions that might interfere with the study, are pregnant or breastfeeding, are participating in another clinical trial simultaneously, or have allergies to the study medication or similar drugs.

The treatment involves norepinephrine administered intravenously in diluted form to increase blood pressure, with the goal of achieving a target blood pressure for at least 24 hours. The infusion is evaluated by a stroke neurologist with adjustments made as necessary. Participants are monitored during infusion for potential side effects such as headache, chest pain, or changes in heart rate, with functional independence assessed at 90 days using the modified Rankin Scale, along with additional evaluations including cognitive assessments and screening for anxiety and depression.

Study on Redasemtide for Adults with Acute Ischemic Stroke Not Eligible for Standard Treatments

This trial evaluates redasemtide (S-005151) in adult patients who have experienced acute ischemic stroke and are not eligible for tissue plasminogen activator or thrombectomy. Participants receive either redasemtide treatment or placebo through intravenous infusion within 25 hours of stroke onset, with monitoring over time to assess recovery and any changes in condition.

The main inclusion criteria require being a male or female adult 18 years or older, able to give informed consent (or have a legal representative do so), having a diagnosis of ischemic stroke in a specific brain area confirmed by CT or MRI scan, being able to start study treatment within 25 hours of stroke onset (or last time known to be well if exact time is unknown), not being eligible for thrombolysis or endovascular therapy, having an NIHSS score between 8 and 22, being medically stable at the time of joining the study, weighing between 30 kg and 150 kg, and for females, not being pregnant or breastfeeding and using reliable birth control if able to have children (with negative pregnancy test before starting).

Exclusion criteria include recent heart attack, severe liver or kidney disease, pregnancy or breastfeeding, uncontrolled high blood pressure, history of bleeding disorders, major surgery in the last 3 months, active cancer, severe mental health conditions, or current participation in another clinical trial.

The investigational drug redasemtide is administered through intravenous infusion, with participants monitored using the modified Rankin Scale (mRS) and NIHSS score to assess recovery, including vital signs such as blood pressure, body temperature, respiratory rate, and pulse rate at regular intervals. Follow-up assessments occur at Day 30, Day 90, and Day 180 to track changes in health status and recovery.

Summary

The ongoing clinical trials for ischaemic stroke demonstrate a diverse range of research approaches across multiple countries. France leads with the highest number of trials, followed by Spain and Germany, indicating strong European engagement in stroke research. The trials investigate various treatment modalities including neuroprotective agents, anticoagulants, antiplatelet therapies, stem cell treatments, and procedural techniques.

Several medications are being tested across multiple trials, including JX10, tenecteplase, redasemtide, and asundexian, suggesting particular research interest in these compounds. Many trials focus on acute treatment within specific time windows after stroke onset, typically ranging from 4.5 to 24 hours, highlighting the critical importance of early intervention.

The research encompasses different patient populations, from newborns with perinatal stroke to elderly patients up to 90 years old, and includes studies specifically designed for patients who cannot receive standard treatments. Common assessment tools across trials include the modified Rankin Scale, NIHSS score, and various quality of life measurements, providing standardized outcome measures.

Notable focus areas include blood pressure management during and after procedures, inflammation reduction, blood clot prevention, and neurological recovery enhancement. Several trials are investigating combination therapies, comparing new medications or approaches with standard care or placebo. The geographic diversity of trial locations offers opportunities for patients across Europe to access cutting-edge treatments while contributing to stroke research advancement.

Ongoing Clinical Trials on Ischaemic stroke

  • A study testing tenecteplase given directly into the artery after blood clot removal in patients with acute ischemic stroke in the front part of the brain

    Recruiting

    1 1
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    Germany

  • Study of cangrelor and acetylsalicylic acid in patients with ischemic stroke requiring emergency carotid artery stenting and mechanical thrombectomy

    Recruiting

    1 1 1
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    Austria

  • A Study of Tenecteplase for Acute Ischemic Stroke in Patients Taking Direct Oral Anticoagulants

    Recruiting

    1 1 1
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    Germany

  • Study of alteplase and tenecteplase for intravenous thrombolysis in patients with ischemic stroke who are taking direct oral anticoagulants

    Recruiting

    1 1 1 1
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    Austria Belgium Finland France Germany The Netherlands +3

  • Study of Cerebrolysin to improve arm function in patients recovering from ischemic stroke

    Recruiting

    1 1 1
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    Romania

  • Study of drug combination therapy for prevention of recurrent stroke in patients with acute ischemic stroke and atrial fibrillation

    Recruiting

    1 1 1 1
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    Germany The Netherlands Spain

  • Study on JX10 for Improving Outcomes in Patients with Acute Ischemic Stroke

    Recruiting

    1 1
    Investigated diseases:
    Belgium Bulgaria Finland France Germany Greece +7

  • Study on the Effectiveness of Tenecteplase in Patients with Acute Ischemic Stroke Taking Rivaroxaban, Apixaban, or Edoxaban

    Recruiting

    1 1 1 1
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    Denmark Norway Sweden

  • Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

    Recruiting

    1 1 1
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    Investigated drugs:
    Poland

  • Study on the Use of Alteplase and Andexanet Alfa for Patients with Acute Ischemic Stroke on Non-Vitamin K Oral Anticoagulants

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

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