Clinical trial phase 1/2 to verify the safety of oral clarified açaí extract in acute ischemic stroke

Randomized and controlled clinical trial, single-center phase 1/2, to verify the safety of oral clarified açaí extract in acute ischemic stroke (AÇA-ICTUS study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-96bp2pb

Enrollment

Unknown

Registered

2025-01-30

Start date

2025-02-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral infarction

Interventions

This will be an exploratory trial to assess the safety and effectiveness of açaí extract in protecting brain tissue from ischemic and reperfusion injury that occurs during and after ischemic stroke. A

B01.875.800.575.912.250.093.480

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years or older; diagnosis of ischemic stroke on admission; absence of bleeding on admission cranial tomography; National Institute of Health Stroke Scale equal or higher than 5 on admission; possibility of administering treatment within 24 hours from the onset of symptoms

Exclusion criteria

Exclusion criteria: Previous moderate functional disability (modified Rankin Scale equal or higher than 3); indication of thrombolytic therapy (chemical, mechanical); inability to tolerate or accept study procedures; co-occurrence of other serious clinical emergencies/urgencies on admission (e.g., cardiopulmonary arrest, acute respiratory failure, septic shock, status epilepticus, signs of intracranial hypertension); National Institute of Health Stroke Scale equal or higher than 20 on admission

Design outcomes

Primary

Measure	Time frame
We aim to check for changes in parameters (vital signs, physical examination, hematologic tests, routine urine, general biochemistry, lipid profile, electrocardiogram). The severity of adverse events will be graded according to the National Institute of Cancer Common Terminology Criteria for Adverse Events (NCI CTCAE)	—

Secondary

Measure	Time frame
We aim to check for change in cerebral infarct volume on cranial tomography (D0 to D5, and from D5 to D90), National Institute of Health Stroke Scale (D0 to D5, and from D5 to D90), modified Rankin Scale (D5 to D90), occurrence of depressive symptoms on D90, change in the metabolomic profile of plasma/serum and urine (D0 to D5), and occurrence of serious clinical events (symptomatic hemorrhagic transformation, cerebral edema with midline shift, death) between D0 and D90	—

Measure

Time frame

We aim to check for change in cerebral infarct volume on cranial tomography (D0 to D5, and from D5 to D90), National Institute of Health Stroke Scale (D0 to D5, and from D5 to D90), modified Rankin Scale (D5 to D90), occurrence of depressive symptoms on D90, change in the metabolomic profile of plasma/serum and urine (D0 to D5), and occurrence of serious clinical events (symptomatic hemorrhagic transformation, cerebral edema with midline shift, death) between D0 and D90

—

Countries

Brazil

Contacts

Public ContactBruno Santos-Lobato

Instituto de Ciências da Saúde da Universidade Federal do Pará

bruls4@ufpa.br+55 (91) 3201-6862

Outcome results

None listed

Source: REBEC (via WHO ICTRP)