New combo therapy shows promise in preventing stroke worsening
NCT ID NCT06696820
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether giving a powerful cholesterol-lowering drug (evolocumab) along with standard statins within 48 hours of a stroke could prevent early neurological decline. It included 429 adults with moderate to severe narrowing of brain arteries. The goal was to see if the combo reduces worsening of symptoms and improves recovery over 90 days.
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 PCSK9 inhibitor) combined with atorvastatin or rosuvastatin
- What this could lead to
- If successful, this combination could become a standard early treatment to prevent neurological worsening after a stroke caused by narrowed brain arteries.
- What could go wrong
- This is a Phase 2/3 trial with 429 participants, so results are still preliminary. The open-label design may introduce bias, and there is a risk of bleeding or other side effects from the drug combination.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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429 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Jun 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 years and older
- 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 years. 2. Acute ischemic stroke diagnosed by CT or MRI of the head. 3. Symptom onset to randomization within 48 hours, including wake-up strokes or strokes without a witnessed onset. The time of symptom onset is defined as the "last known normal time." 4. NIHSS score ≤ 20. 5. mRS score of 0-1 prior to the current stroke. 6. Moderate or severe intracranial stenosis or occlusion (≥50%) confirmed by CTA, MRA, or DSA, involving the responsible intracranial arteries: intradural internal carotid artery, M1-2 segments of the middle cerebral artery, A1 segment of the anterior cerebral artery, V4 segment of the vertebral artery, basilar artery, or P1 segment of the posterior cerebral artery. 7. The participant or legal representative has signed the informed consent form. Exclusion Criteria: 1. Cardiogenic embolism (e.g., atrial fibrillation, cardiac valvular disease, etc.). 2. Symptomatic intracranial stenosis or occlusion due to arteritis, arterial dissection, moyamoya disease, or other similar conditions. 3. Patients who have received intravenous thrombolysis or mechanical thrombectomy. 4. Use of PCSK9 inhibitors within the 1 month prior to the onset of the stroke. 5. Allergy to statins or PCSK9 inhibitors. 6. Active liver disease, including unexplained persistent elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST). 7. Known severe renal impairment (creatinine clearance \<30 mL/min). 8. Myopathy. 9. Concurrent use of cyclosporine. 10. Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization. 11. Life expectancy \<3 months (e.g., due to severe cardiopulmonary disease, renal failure, malignancy, or other terminal conditions). 12. Participation in other interventional clinical trials that may impact outcome assessments. 13. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation or poses significant risks to the patient.
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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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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
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Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
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