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NOT YET RECRUITING
NCT07341958
NA

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

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 (≥50 mg/dL).

Official title: INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2):A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Key Details

Gender

All

Age Range

35 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

242

Start Date

2026-02-01

Completion Date

2027-08-30

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

Tafolecimab

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.

DRUG

Placebo

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.

Locations (1)

Beijing Tiantan Hopital, Capital Medical University

Beijing, China