INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)

ConditionIschemic Stroke or High-risk TIA (ABCD² ≥ 4)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35-80

SponsorBeijing Tiantan Hospital

About this trial

The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) \[Lp(a)\] levels and the risk of stroke recurrence within 90 days in patients with ischemic stroke or high-risk TIA (ABCD² ≥ 4) accompanied by elevated lipoprotein(a) levels (≥30 mg/dL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 35 and 80 years, regardless of gender.

For patients with prior lipid-lowering treatment: screening LDL-C ≥1.8 mmol/L; for treatment-naïve patients: screening LDL-C ≥2.6 mmol/L.

Lp(a) ≥30 mg/dL.

Onset of symptoms within 3 to 7 days.

Disqualifiers

Have received or are planned to receive intravenous thrombolysis or endovascular thrombectomy;

Definite cardioembolic ischemic cerebrovascular disease, such as that associated with atrial fibrillation, prosthetic heart valves, atrial myxoma, endocarditis, etc.;

Ischemic cerebrovascular disease with other definite etiologies, such as aortic dissection, cervical or intracranial arterial dissection, vasculitis, vascular malformation, moyamoya disease/moyamoya syndrome, fibromuscular dysplasia, etc.;

Non-vascular intracranial diseases, such as intracranial tumors, multiple sclerosis, etc.;

Trial design

Design model

Parallel

Treatments tested in this trial

Tafolecimab
Drug
Treatment should be initiated as soon as possible after randomization, with Tafolecimab administered subcutaneously once every two weeks for a total duration of 90 days. All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses.
Placebo
Drug
Treatment should be initiated as soon as possible after randomization, with Tafolecimab placebo administered subcutaneously once every two weeks for a total duration of 90 days. All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses.

Treatment groups

242 Participants

are divided into 2 treatment groups

Group A: Standard lipid-lowering therapy(statin therapy with or without ezetimibe) + TafolecimabExperimental treatment 1 intervention

Group B: Standard lipid-lowering therapy (statin therapy with or without ezetimibe)+Tafolecimab placeboPlacebo comparator 1 intervention