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New treatment option for ICH - Intracerebral Hemorrhage
Official title Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage
ClinicalTrials.gov ID: NCT06504576
What this study is testing
What is Pletaal 100mg/tab?
Pletaal 100mg/tab is an investigational medicine, being studied as a potential treatment for ich - intracerebral hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Intracerebral hemorrhage (ICH) is a dangerous form of stroke with high mortality rate. Other than evacuating the hematoma with surgical procedures, there is no current effective internal medicine treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- Adult patients (at least 20 years old, up to 80 years old)
- ICH located in the thalamus or basal ganglia.
- ICH score less than 3 (hematoma volume not greater than 15 ml) and was admitted within 24 hours since onset.
- The patient or his/her legal representative agrees to join this trial and accept the arrangements of tests within this trial.
- Patients with normal bone marrow and hematopoiesis (Red blood cell count, white blood cell count, platelet count within reference value).
You likely can't join if
- Image studies conducted after intracerebral incidence and before enrollment showing higher bleeding risks such as spot sign in computed tomography...
- Intracerebral hemorrhage located in the cerebral area, below the cerebellar tentorium or ICH score greater than 3 (not including 3).
- Surgical intevention such as decompressive craniotomy or hematoma evacuation was suggested after evaluation by neurosurgeon.
- Patients with history of brain trauma, structural brain disease, metabolic brain disease, neuroinflammatory disease or brain neoplasms.
- Patients that cannot tolerate image studies, including but not limited to those that cannot cooperate, affecting image quality due to agitation...
- Patients with medical contraindications to MRI contrast medium, including chronic renal failure (Creatinine clearance rate less than 30ml/min).
See the full eligibility criteria
- Adult patients (at least 20 years old, up to 80 years old)
- ICH located in the thalamus or basal ganglia.
- ICH score less than 3 (hematoma volume not greater than 15 ml) and was admitted within 24 hours since onset.
- The patient or his/her legal representative agrees to join this trial and accept the arrangements of tests within this trial.
- Patients with normal bone marrow and hematopoiesis (Red blood cell count, white blood cell count, platelet count within reference value).
- Patients with normal liver function (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Gamma-glutamyl transferase (γ-GT) within reference value)
- Patients with normal renal function (Blood urea nitrogen (BUN), creatinine and estimated glomerular filtration rate (eGFR) within reference value)
- Patients with normal coagulation function (Platelet count, prothrombin time (PT), activate partial thromboplastin time (aPTT), international normalized ratio (INR) within reference value)
- Image studies conducted after intracerebral incidence and before enrollment showing higher bleeding risks such as spot sign in computed tomography angiography, new intraventricular hemorrhage (IVH), IVH expansion...
- Intracerebral hemorrhage located in the cerebral area, below the cerebellar tentorium or ICH score greater than 3 (not including 3).
- Surgical intevention such as decompressive craniotomy or hematoma evacuation was suggested after evaluation by neurosurgeon.
- Patients with history of brain trauma, structural brain disease, metabolic brain disease, neuroinflammatory disease or brain neoplasms.
- Patients that cannot tolerate image studies, including but not limited to those that cannot cooperate, affecting image quality due to agitation, presenting with unstable hemodynamics, installed with pacemakers...
- Patients with medical contraindications to MRI contrast medium, including chronic renal failure (Creatinine clearance rate less than 30ml/min).
- Patients currently pregnant or expecting pregnancy or breastfeeding in six months.
- Patients taking oral anti-platelet medication (aspirin, clopidogrel, ticagrelor, cilostzaol) or anti-coagulant (warfarin, dabigatran, rivaroxaban, apixaban, edoxaban) when ICH occurred.
- Patients with medical contraindications to cilostazol, including heart failure with any severity, any coagulopathy, ventricular tachycardia, ventricular fibrillation, mulitfocal ventricular arrhythmia, severe...
- Patients with poor blood pressure control (defined as systolic blood pressure greater than 160 mmHg under anti-hypertensive medication).
- Patients with unstable neurological conditions (defined as increase in National Institute of Health Stroke Scale (NIHSS) greater than 4 or newly occurred conscious change during admission).
- Patients with life expectancy less than three months.
- Patients with known allergy to any of the ingredient of the trial medication, and deemed unsuitable for enrollment of the study by the trial host.
- Patient or legal guardian of the patient refuses to be enrolled within the study.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Not Required For This Country, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Not Required For This Country, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.