Combining PCSK9 inhibitors and statins for treating acute ischemic stroke

Efficacy and Safety of Early Combined Therapy With PCSK9 Inhibitors and Statins in Acute Ischemic Stroke (CAPTAIN)--A Multicenter, Prospective, Randomized Trial

This study is testing if giving a new heart medication along with standard cholesterol-lowering drugs can help people who have just had a stroke feel better and avoid worsening symptoms.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 429 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: evolocumab, alirocumab
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06696820 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of early combined therapy using PCSK9 inhibitors and statins in patients with acute ischemic stroke caused by symptomatic intracranial large vessel atherosclerotic stenosis. Patients will be randomly assigned to receive either a single injection of evolocumab along with standard statin therapy or standard statin therapy alone within 48 hours of symptom onset. The primary goal is to determine if this combination therapy can reduce the incidence of early neurological deterioration. The study employs a multicenter, prospective, open-label design to ensure robust data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an acute ischemic stroke with moderate to severe symptomatic intracranial stenosis.

Not a fit: Patients with cardiogenic embolism or those with symptomatic intracranial stenosis due to conditions like arteritis or arterial dissection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of early neurological deterioration in patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies have shown that statin therapy can improve outcomes in stroke patients, but the combination with PCSK9 inhibitors is a novel approach that has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Xiang Luo

Conditions: Acute Ischemic Stroke, PCSK9 inhibitor