Phase 2 Stroke Trial, Recruiting

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:

• People aged 18 to 80 years old
• People who have been diagnosed with an acute ischemic stroke (a stroke caused by a blockage in a blood vessel in the brain) according to current medical guidelines
• People who have not received, and are not planned to receive, the standard clot-dissolving treatment given through a drip within 24 hours of their stroke, and for whom the first dose of the trial drug can be given within 24 hours of the stroke starting
• People whose stroke severity, measured using a standard medical scoring tool called the NIHSS, falls between 6 and 20, and whose arm and leg weakness scores on that same tool add up to at least 2
• People who were largely independent before the stroke, with a disability score of 1 or less on a standard scale called the mRS
• People (or their legal guardian, if they are unable to sign) who have given written consent to take part

Who may not be able to join:

• People who have any bleeding in or around the brain, such as a bleeding stroke, blood clots on the brain, or bleeding in the fluid surrounding the brain
• People with any of the following allergy histories: an allergy to the trial drug or similar substances; an allergy to contrast dyes or materials used in medical scans; an allergy to any medicines, medical devices, or products made from pigs or other mammals (such as certain types of insulin); or a history of severe allergic reactions (such as anaphylactic shock or severe swelling) or known allergies to two or more drugs with different chemical structures
• People known to have a condition called alpha-1 antitrypsin deficiency
• People with severe problems with consciousness or awareness, as measured by a score of 2 or more on a specific part of the NIHSS scale
• People whose brain scan (CT or MRI) shows a very large area of stroke damage covering more than one-third of the area supplied by the middle cerebral artery
• People whose stroke symptoms improve rapidly after giving consent, or where the symptoms may be caused by something other than an ischemic stroke
• People who are planning to have, or have already had, a procedure to physically remove or treat the blockage inside a blood vessel (endovascular treatment)
• People who have already been given any of the following medicines since the stroke began: certain listed drugs with brain-protective effects, including edaravone, butylphthalide, citicoline, nimodipine, piracetam, ginkgo-based injections, and several others listed in the criteria, or injections containing specific Chinese herbal ingredients (confirm with trial site for the full list)
• People with severely high blood pressure that remains at or above 185/110 mmHg even after blood pressure-lowering medication has been given
• People who have taken a type of blood pressure medicine called an ACE inhibitor (such as captopril or lisinopril) in the 7 days before screening, or who plan to take one during the trial
• People whose blood pressure dropped very low (systolic below 100 mmHg or mean arterial pressure below 65 mmHg) at any point after the stroke and before joining the trial
• People who have an active serious infection that requires treatment with antibiotics or other infection-fighting medicines given throughout the body
• People with severe kidney problems, including very high creatinine levels in the blood, low kidney filtration rates, kidney failure, or uremia
• People with severe liver problems, including significantly raised liver enzyme levels, liver failure, cirrhosis, high pressure in the liver's blood vessels, or active hepatitis
• People with moderate to severe heart failure (graded as Class II or above by the NYHA classification system), or a past history of congestive heart failure
• People who currently have a cancer diagnosis or are receiving cancer treatment
• People who are pregnant, breastfeeding, or planning to become pregnant
• People with a history of epilepsy, seizure-like symptoms during the stroke, severe mental health conditions, intellectual disability, or dementia
• People suspected or confirmed to have alcohol dependence, or who drank more than 3 units of alcohol (men) or 2 units (women) in the 24 hours before the stroke (1 unit equals approximately 360 mL of beer, 45 mL of spirits, or 150 mL of wine)
• People who have taken part in another clinical trial (drug or non-drug) in the 3 months before signing consent, or who are currently enrolled in another clinical trial
• People with serious illness where survival beyond 90 days is not expected
• People who are unable to tolerate blood draws through a vein, experience dizziness or fainting when standing, or are unwilling to receive multiple injections into the muscle as part of the treatment
• People who the trial investigators consider unsuitable for any other reason

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