Tests a drug cocktail for brain swelling after large stroke

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a large stroke in the middle cerebral artery area within the last 3 days and are not planned for decompressive craniectomy (surgery to relieve brain swelling).

Age

18 years or older

Sex

All sexes can join.

Disease stage

Acute ischemic stroke in the middle cerebral artery (MCA) area, with symptoms starting within 3 days (≤72 hours) before randomization. Infarct volume of 80-300 mL, or ASPECTS 1-5 involving at least two cortical regions.

Earlier treatment

Not scheduled for decompressive craniectomy (either not indicated or declined by the patient or family).

Main reasons for not taking part

• Signs of brain herniation or severe low blood pressure (SBP <90 mmHg) at the start
• Reasons not to take the study drugs (terazosin, urapidil, esmolol, propranolol), such as asthma or severe slow heartbeat
• Severe other illnesses that could interfere with checking results or safety, such as end-stage organ failure or advanced cancer
• Pregnancy or breastfeeding
• Taking part in another interventional trial that may influence the results

The registry criteria, word for word

What the trial wants to find out

Large ischemic stroke is a severe subtype of acute ischemic stroke (AIS), often leading to malignant cerebral edema, elevated intracranial pressure, and poor functional outcomes. Despite early aggressive treatment, malignant cerebral edema remains a major determinant of prognosis, even in cases of successful recanalization. Preclinical studies suggest that a pharmacological cocktail (PPA) may alleviate cerebral edema by modulating extracellular potassium balance, maintaining aquaporin-4 expression, and enhancing lymphatic drainage.

The 2 groups in the trial

• PPA Intervention GroupTreatment being tested

  Participants in this group will receive a pharmacological cocktail (PPA) for five days in addition to standard medical treatment for acute ischemic stroke. The regimen includes terazosin or urapidil, and propranolol or esmolol, with individualized blood pressure management. The specific protocol is as follows: * Terazosin (no less than 1 mg orally or via nasogastric tube, nightly) or Urapidil (100 mg in 30 mL saline, IV infusion at no less than 2 mL/h) * Propranolol (10 mg orally or via nasogastric tube, three times daily) or Esmolol (1 g in 40 mL saline, IV infusion at no less than 2 mL/h; use for no more than 48 hours. Beyond 48 hours, switch to Propranolol)

  Treatment: PPA Intervention

• Standard Treatment GroupNo study treatment, for comparison

  Participants in this group will receive standard medical treatment for acute ischemic stroke without the PPA intervention. This includes appropriate supportive care, blood pressure management according to clinical guidelines, and symptomatic treatment as required.