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New drug combo may shrink bleeding plaques in neck arteries, cutting stroke risk

NCT ID NCT07586540

Disease control Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding alirocumab (a cholesterol-lowering injection) to standard statin therapy can reduce bleeding inside fatty plaques in the carotid artery. About 280 people with a recent mini-stroke or stroke due to a 50-69% blocked neck artery will receive either alirocumab or a placebo every two weeks for 26 weeks, with MRI scans to measure plaque changes. The goal is to see if the drug makes plaques less dangerous and lowers the chance of future strokes.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2027

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

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

40 to 80 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

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 ≥ 40 and ≤ 80 years 2. Recently symptomatic (TIA, amaurosis fugax, or non-disabling ischaemic stroke with mRS ≤ 2) referable to a carotid territory within 28 days of randomisation 3. Ipsilateral extracranial internal carotid artery stenosis of 50-69% by NASCET criteria on CTA or DSA 4. HR-VW-MRI evidence of IPH (MPRAGE hyperintensity ≥150% of adjacent sternocleidomastoid) OR LRNC ≥ 10% of plaque volume in the symptomatic plaque 5. On a stable dose of high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for ≥ 4 weeks, or able and willing to initiate atorvastatin 80 mg daily at randomisation 6. LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening 7. Able to undergo 3T MRI (no contraindications) 8. Provides written informed consent Exclusion Criteria: 1. Indication for urgent carotid revascularisation within 14 days per treating team 2. Disabling stroke (mRS \> 2) or NIHSS \> 5 at randomisation 3. Carotid stenosis ≥ 70% or occlusion 4. Cardioembolic stroke source (atrial fibrillation, LV thrombus, endocarditis, PFO with high-risk features) 5. Intracranial haemorrhage within 12 months or any history of symptomatic ICH 6. eGFR \< 30 mL/min/1.73 m² 7. Active hepatobiliary disease or ALT/AST \> 3x ULN 8. Prior exposure to any PCSK9 inhibitor or inclisiran within 6 months 9. Known hypersensitivity to alirocumab or excipients 10. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential 11. Life expectancy \< 24 months 12. Participation in another interventional trial within 30 days 13. Inability to comply with follow-up or MRI schedule

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Conditions

The condition(s) this trial relates to.

carotid stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carotid stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aga Khan University

    Karachi, Pakistan

  • Ain Shams University

    Cairo, Egypt

  • Alexandria University, Smouha University Comprehensive Stroke Center

    Alexandria, Egypt

  • Amman Specialized IR Center

    Amman, Jordan

  • Cairo University

    Cairo, Egypt

  • Centre Hospitalier Universitaire Ibn Sina de Rabat

    Rabat, Morocco

  • Department of Neurology, Eskisehir Osmangazi University

    Eskişehir, Turkey (Türkiye)

  • Institut National de Neurologie

    Tunis, Tunisia

  • King Abdulaziz Medical City

    Jeddah, Saudi Arabia

  • King Abdullah Medical City

    Mecca, Saudi Arabia

  • King Khalid University

    Abhā, Saudi Arabia

  • Neurology Department, Al-Azhar University

    Cairo, Egypt

  • Neurology Department, Dr. Lutfi Kirdar City Hospital

    Istanbul, Turkey (Türkiye)

  • Weill Cornell Medicine-Qatar

    Doha, Qatar

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