New drug combo after stroke shows promise in preventing early decline
NCT ID NCT07295366
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This study tested whether giving a powerful cholesterol-lowering drug (evolocumab) within 6 hours after a stroke procedure (thrombectomy) could prevent early neurological worsening. 60 adults with large-vessel stroke were randomly assigned to receive either the drug plus standard care or standard care alone. The main goal was to see if the drug reduced the chance of early decline or death within a week.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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60 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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May 2026
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 old, gender not limited, gender ratio not limited. 2. The clinical diagnosis was acute ischemic stroke with occlusion of the anterior circulation large vessels. CTA/DSA confirmed that the responsible vessel for this stroke occlusion was located in the intracranial segment of the internal carotid artery and the M1 segment of the middle cerebral artery. 3. The time from onset to puncture is within 24 hours, and the patient receives mechanical thrombectomy (MT) (including direct thrombectomy and intravenous thrombolysis bridging thrombectomy), with postoperative vascular recanalization reaching mTICI grade 2b or 3. The surgical indications and time window follow the current guidelines and imaging criteria of key randomized controlled trials (RCTs). The definitions are as follows: Early window (0-6 h): Meeting the usual EVT indications (anterior circulation LVO, baseline NIHSS ≥ 6, ASPECTS ≥ 6, or center-defined criteria), the interventional team decides to perform MT; Late window (6-24 h): Meeting one of the imaging selection criteria of DAWN or DEFUSE-3 (based on CTP-RAPID or MRI-DWI/perfusion): ·DAWN (6-24 h) (any one): Age ≥ 80 years: NIHSS ≥ 10 and core infarct volume \< 21 mL; Age \< 80 years: NIHSS ≥ 10 and core \< 31 mL; Age \< 80 years: NIHSS ≥ 20 and core 31-51 mL. • DEFUSE-3 (6-16 h) (all conditions must be met): Core \<70 mL, mismatch ratio (penumbra/core) ≥1.8, mismatch volume ≥15 mL, and Tmax \>6 s volume \>15 mL. 4. The etiological classification is intracranial arteriosclerosis-LAA (ICAD-LAA). The definition is as follows: imaging evidence supports the presence of atherosclerotic stenosis/plaque in the responsible vessel (such as severe stenosis/occlusion of the proximal internal carotid artery or middle cerebral artery) and the patient has corresponding underlying atherosclerosis (such as other intracranial/extracranial artery stenosis, hypertension, diabetes, etc.). 5. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points. 6. Before the onset of the disease, the patient had good daily living abilities and an mRS score ≤ 2 (no severe disability). 7. Able to complete the injection of research drugs as required. 8. The patient or his or her legal representative shall sign a written informed consent form, understand the research content and agree to cooperate with the follow-up. Exclusion Criteria: 1. Non-atherosclerotic lesions (such as arterial dissection, Moyamoya disease, vasculitis, embolism of unknown origin, etc.). 2. Patients who present with significant intracranial hemorrhage or excessively large cerebral infarction volume upon admission, making them unsuitable for continued participation in the study. 3. The cause of stroke is cardioembolism (such as a history of heart disease such as atrial fibrillation or valvular heart disease). 4. Individuals with a clear history of allergy to evolocumab or its excipients. 5. Patients with severe liver and kidney dysfunction: baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal, or significantly reduced creatinine clearance (eGFR \< 30 mL/min/1.73m²). 6. Patients with active severe infection, immune system disease or other serious comorbidities that may significantly affect prognosis (such as active tumors, terminal diseases, etc.). 7. Patients who have been treated with PCSK9 inhibitors within the past 4 weeks (to avoid affecting the study due to changes in tolerance or mechanism of action). 8. Pregnant or lactating women. 9. Expected survival \<90 days or accompanied by other serious diseases. 10. Currently participating in other interventional clinical studies.
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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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Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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