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New treatment option for Stroke
Official title Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion
ClinicalTrials.gov ID: NCT07002476
What this study is testing
What is guideline-recommended SoC?
guideline-recommended SoC is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for stroke.
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
- A prospective, multicenter, open-label, randomized controlled study to assess the effects of early intensive lipid-lowering initiated before endovascular treatment setting on (i) functional outcome in patients with acute ischemic stroke between preoperative intensive lipid-lowering therapy with PCSK9 inhibitor (PCSK9i) and guideline-recommended standard of care (SoC)(ii) safety in these patients.
- Phase 3: a large, late-stage study
- 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 18 and older
You may be able to join if
- Adults (age 18 years and older);
- Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral...
- Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;
- Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local...
You likely can't join if
- ASPECTS score ≤5 on cranial CT imaging;
- Pre-existing functional impairment, with mRS score \>2;
- Patients who are allergic to PCSK9 inhibitors;
- Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;
- Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 at final screening;
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit...
See the full eligibility criteria
- Adults (age 18 years and older);
- Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2);
- Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;
- Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements).
- ASPECTS score ≤5 on cranial CT imaging;
- Pre-existing functional impairment, with mRS score \>2;
- Patients who are allergic to PCSK9 inhibitors;
- Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;
- Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 at final screening;
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal;
- Severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months;
- Pregnant or lactating women;
- Patients who are participating in other clinical trials;
- Other conditions deemed unsuitable for inclusion in the clinical study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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.