Intracranial Hemorrhage Risk of Intensive Statin in Acute Ischemic Stroke With Cerebral Microbleeds (NCT05589454) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Intracranial Hemorrhage Risk of Intensive Statin in Acute Ischemic Stroke With Cerebral Microbleeds
China344 participantsStarted 2023-01
Plain-language summary
This study is the first and largest secondary prevention trial about lipid-lowering therapy for acute ischemic stroke patients at high-risk of intracranial hemorrhage.
The primary hypothesis of this study is: excessive reduction in serum lipid levels by intensive statin therapy in acute ischemic stroke patients with cerebral microbleeds can increase the risk of intracranial hemorrhage.
This study will shed light on new clinical decisions regarding the long-term serum lipid management in these patients with dilemma in clinical practice.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients with a non-cardioembolic ischemic stroke within 14 days prior to entry to the study
✓. Adults between the ages of 18 and 85
✓. Patients with cerebral microbleeds on baseline SWI imaging
✓. Patients or their legal representatives volunteer to participate and sign written informed consent
Exclusion criteria
✕. Patients with severe acute ischemic stroke (NIHSS score ≥21)
✕. Patients with coma (GCS score \< 8)
✕. Patients with previous moderate to severe dependence (mRS score 3-5)
✕. Patients with any contraindications to CT and MRI (such as metal implants, claustrophobia, etc.)
✕. Patients who are allergic to atorvastatin or excipients
✕. Patients with intracranial hemorrhagic diseases confirmed by CT or MRI, such as cerebral hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, traumatic cerebral hemorrhage or hemorrhagic conversion of infarcts, etc
What they're measuring
1
The incidence of hemorrhagic strokes
Timeframe: From date of randomization until the date of the first occurrence of hemorrhagic stroke, assessed up to 36 months
2
Changes in degree of cerebral microbleeds
Timeframe: From date of randomization until the end of the study, assessed up to 36 months
✕. Patients within 6 months after hemorrhagic stroke
✕. Patients with hemorrhagic tendency, such as abnormal coagulation function, Henoch-Schonlein purpura, platelet count less than 100×109/L or abnormal platelet function, etc