Cholesterol drug tested to stop stroke worsening
NCT ID NCT07301372
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This study tested whether giving the cholesterol-lowering drug evolocumab within 24 hours after clot-busting treatment (thrombolysis) can prevent early neurological decline in people with acute ischemic stroke. 132 participants were randomly assigned to receive evolocumab plus standard care or standard care alone. The main goal was to see if evolocumab reduced worsening of stroke symptoms in the first week.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- evolocumab (a cholesterol-lowering drug)
- What this could lead to
- If it works, this could point toward a way to prevent early neurological decline after a stroke, potentially improving recovery.
- What could go wrong
- This is a small, single-center, open-label trial, so results may not be definitive or apply broadly. The drug also does not eliminate the need for ongoing statin therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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132 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1\. Age 18-85 years. No gender or sex restrictions, and no gender ratio restrictions. 2\. Clinically diagnosed with acute ischemic stroke, with the time from symptom onset to intravenous thrombolysis \<9 hours. 1. Within 4.5 hours of symptom onset: This time window is based on the ECASS III criteria (Class IA recommendation) and is currently the standard indication for intravenous thrombolysis in acute ischemic stroke worldwide. 2. 4.5-9 hours: Referring to the EXTEND study criteria, meeting the following multimodal imaging mismatch ratio: ischemic penumbra volume/ischemic core volume \>1.2, with an absolute mismatch volume \>10 mL and an ischemic core volume \<70 mL. 3\. The stroke meets the TOAST classification for large artery atherosclerosis (LAA), which includes intracranial arteriosclerosis (ICAS) and extracranial arteriosclerosis (ECAS), and meets one of the following three criteria: large artery stenosis ≥50%, infarct lesion \>1.5cm + ipsilateral plaque (no stenosis requirement), or intracranial artery stenosis ≥30% with plaque ulceration. 4\. The patient or their legal representative has signed an informed consent form. Exclusion Criteria: 1\. CT scan showing signs of intracranial hemorrhage, symptomatic intracranial hemorrhage, or subarachnoid hemorrhage, even if the CT scan results are normal. 2\. Patients who must or wish to continue using restrictive medications or any medications that may interfere with the safe conduct of the trial. 3\. Acute bleeding tendency, including but not limited to: 1. A known family history of bleeding disorders and a history of a serious bleeding disorder currently present or within the past 6 months. 2. Receiving heparin treatment within the past 48 hours, with an activated partial thromboplastin time (aPTT) exceeding the upper limit of the normal range for laboratory testing. 3. Currently taking an oral vitamin K anticoagulant (e.g., warfarin) with a prolonged prothrombin time (INR \> 1.7 or PT \> 15 seconds); or currently taking a novel oral anticoagulant (e.g., dabigatran etexilate, rivaroxaban, or apixaban) with an activated partial thromboplastin time (aPTT) and/or prothrombin time (PT) exceeding the upper limit of the local laboratory reference range. 4. Platelet count below 100,000/mm³ at screening. 5. History of central nervous system injury (e.g., tumor, aneurysm, intracranial or spinal surgery). 6. Experiencing traumatic external cardiac compression, obstetric delivery, or non-compressive vascular puncture (e.g., subclavian or jugular vein puncture) within the past 10 days. 7. Known history of suspected intracranial hemorrhage or suspected aneurysm/subarachnoid hemorrhage. 8. Tumors with increased bleeding risk. 9. History of ulcerative gastrointestinal disease, esophageal varices, aneurysm, or arteriovenous malformation within the past 3 months. 10. Associated with bleeding risk. 4. Any known disease significantly associated with this condition. 4\. Previous mRS score ≥2, with comorbid dementia or other neurodegenerative diseases. 5\. Clinically confirmed non-atherosclerotic intracranial arterial stenosis, such as aortic dissection, vasculitis, moyamoya disease, embolism, immune system disorders, etc. 6\. Other comorbid medical histories that may affect endpoint event determination and follow-up, such as history of traumatic brain injury, multiple sclerosis, encephalitis, tumors, poisoning, syphilis, and severe heart, lung, liver, kidney, or endocrine diseases. 7\. Pregnant women. 8\. Currently participating in other experimental device or drug studies, or having completed other experimental device or drug studies, or having received other experimental treatments for less than 30 days. 9\. Having used PCSK9 inhibitors within 4 weeks prior to enrollment. 10\. Hypersensitivity to statins or PCSK9 inhibitors. 11\. Patients with severe hepatic or renal impairment (eGFR \<30 ml/min/1.73 m²). 12\. Refusal to sign informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Neurology
Xuzhou, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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