Health TrialsbyHealthPanel

PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis

ConditionSymptomatic Intracranial Atherosclerotic Stenosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-80
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Insulin dependent diabetes for at least 15 years.

At least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dL or HDL < 40 mg/dL or fasting triglycerides > 150 mg/dL or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event.

History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.

Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic.

Disqualifiers

Baseline NIHSS ≥26.

Suspected cardiogenic ischemic cerebrovascular diseases (e.g., combined with atrial fibrillation, heart valve prosthesis, atrial myxoma, endocarditis, etc.).

Source of symptoms is possible related to ipsilateral carotid disease.

Other ischemic cerebrovascular diseases with specific causes (e.g., aortic dissection, vasculitis, vascular malformation, etc.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recaticimab

    Drug

    Recaticimab 300mg subcutaneous Q8W for 1 year.

  • Placebo

    Drug

    Matched placebo subcutaneous Q8W for 1 year.

Treatment groups

5,276 Participants
are divided into 2 treatment groups
Group A: Recaticimab groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Any new stroke

Any new ischemic or hemorrhagic stroke within 1 year

Time frame
1 year (±2) weeks

Secondary outcomes

1

Composite cardiovascular events

Composite cardiovascular events (non-fatal stroke, myocardial infarction, and death from cardiovascular causes) within 1 year.

Time frame
1 year (±2) weeks
2

Ischemic stroke

Any new ischemic stroke within 1 year.

Time frame
1 year (±2) weeks
3

Hemorrhagic stroke

Any new hemorrhagic stroke within 1 year.

Time frame
1 year (±2) weeks
4

Non-fatal stroke

Any non-fatal stroke within 1 year.

Time frame
1 year (±2) weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: