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An Open-label Phase 2b Study with Blinded Evaluation of the Combination of Amodiaquine and Potassium Canrenoate with Exenatide or Glibenclamide in Acute Ischemic Stroke
EU CTIS ID: 2025-522796-28-00
What this study is testing
To evaluate the safety of the investigational treatment compared to best medical therapy (BMT), on hemorrhagic transformation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 to 80 years, inclusive, at the time of signing the informed consent.
- Patient with either no history of depression or treated for depression with a stable combination of antidepressants for at least 8weeks before inclusion in the study.
- Patient with no known history of dementia.
- Provision of signed informed consent by the patient or caregiver/legal representative, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Expectation that the patient will receive standard physical, occupational, and speech rehabilitation therapies as indicated for post-stroke deficits.
- Patient or caregivers understand study procedures and are willing to comply with them for the entire length of the study.
You likely can't join if
- Allergy/sensitivity to study drugs or their ingredients.
- Patient presenting with uncontrolled hypertension, blood glucose level >4 mmol/L, cancer, renal failure (defined as creatinine clearance <90 ml/min), evidence of acute myocardial infarction, acute pancreatitis, or other significant medical condition according to Investigator’s opinion.
- Mental illness or psychiatric disease making the patient incapable of following/participating in this study, as assessed by the Investigator.
- a. Alanine transaminase (ALT) [or aspartate transaminase (AST)] >2.0 x upper limit of normal (ULN) b. Total bilirubin >1.5xULN (Participants with Gilbert’s syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is ≤1.5 x ULN) c. Current or chronic history of liver disease.
- Concurrent treatment with any of the investigational drugs in this study.
- Participation in other clinical trials within 30 days before randomization, or currently involved in other clinical trials.
See the full eligibility criteria
Who can join
- Aged 18 to 80 years, inclusive, at the time of signing the informed consent.
- Patient with either no history of depression or treated for depression with a stable combination of antidepressants for at least 8weeks before inclusion in the study.
- Patient with no known history of dementia.
- Provision of signed informed consent by the patient or caregiver/legal representative, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Expectation that the patient will receive standard physical, occupational, and speech rehabilitation therapies as indicated for post-stroke deficits.
- Patient or caregivers understand study procedures and are willing to comply with them for the entire length of the study.
- Confirmed diagnosis of AIS, according to the World Health Organization (WHO) definition, as diagnosed with CT.
- Radiology-confirmed supratentorial IS; nonlacunar, >15 mm diameter in one direction as depicted in the CT scan.
- NIHSS score at screening ≥5 and ≤20 points.
- A maximum of 36 h may elapse from symptoms’ onset to treatment initiation.
- Pre-stroke (36 hours prior to stroke onset) independent functional status in activities of daily living (ie, patients must have been living without requiring nursing care) based on information provided by the patient or his/her caregivers.
- Patient not a candidate for thrombolysis with tPA.
- Patient not a candidate for thrombectomy.
- A diabetic patient must have been on a stable antidiabetic regimen at least 8 weeks before inclusion in the study.
What rules you out
- Allergy/sensitivity to study drugs or their ingredients.
- Patient presenting with uncontrolled hypertension, blood glucose level >4 mmol/L, cancer, renal failure (defined as creatinine clearance <90 ml/min), evidence of acute myocardial infarction, acute pancreatitis, or other significant medical condition according to Investigator’s opinion.
- Mental illness or psychiatric disease making the patient incapable of following/participating in this study, as assessed by the Investigator.
- a. Alanine transaminase (ALT) [or aspartate transaminase (AST)] >2.0 x upper limit of normal (ULN) b. Total bilirubin >1.5xULN (Participants with Gilbert’s syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is ≤1.5 x ULN) c. Current or chronic history of liver disease.
- Concurrent treatment with any of the investigational drugs in this study.
- Participation in other clinical trials within 30 days before randomization, or currently involved in other clinical trials.
- Signs of intracranial hemorrhage or suspected subarachnoid hemorrhage, as assessed based on CT imaging examination.
- Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency (previously known or as confirmed at the clinical site).
- Treatment with medications/agents which are contraindicated based on the SmPCs of the combination IMPs for usage in combination with the study interventions.
- Current drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of patient or caregiver/legal guardian/representative to give written informed consent.
- Pregnancy or lactation, at screening.
- Patient who plans to become pregnant within 6 months, or women in childbearing age with negative pregnancy test but who refuses to accept contraception.
- Patient unlikely to be available for a 90-day follow-up (eg, life expectancy <3 months).
- Patients with contraindications with the combination of the drugs being studied.
- Clinical presentation of a lacunar stroke according to site investigators.
- Patient suffering from intracranial tumors, severe trauma, encephalitis, subarachnoid hemorrhage, or other brain organic diseases.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.