Safety and Efficacy of Baricitinib After Endovascular Treatment in Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized Controlled Clinical Trial

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of University of Science and Technology of China

About this trial

The primary purpose of this study is to evaluate the efficacy and safety of Baricitinib combined with endovascular therapy in patients with acute anterior circulation large vessel occlusion, to address futile recanalization with priority, and to elucidating the mechanism of JAK/STAT pathway inhibition on neuroprotection and inflammatory regulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age is 18 years old or above.

Diagnosed as anterior circulation large vessel occlusion stroke by CTA, MRA or DSA.

Randomized within 24h after the onset.

The NIHSS score is above 5 and the ASPECT score is above 3 points while receiving imaging examination;

Disqualifiers

Intracranial hemorrhage confirmed by CT or MRI.

mRS score>2 for patients <80 years, or mRS score>1 for those ≥80 years before onset.

Pregnant or lactating women.

Allergic to contrast agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 2mg Baricitinib

    Drug

    One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.

  • 4mg Baricitinib

    Drug

    Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.

  • Placebo

    Drug

    Two 2mg placebo tablets are given three times a day, last for 5±2 days.

  • Guideline-based therapy

    Other intervention

    Guideline-based therapy including EVT treatment is determined by the physician.

Treatment groups

750 Participants
are divided into 3 treatment groups
Group A: 2mg Baricitinib group+Guideline-based therapyExperimental treatment 2 interventions
Group B: Baricitinib 4mg group+Guideline-based therapyExperimental treatment 2 interventions
Group C: Sham group+Guideline-based therapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Distribution of 90-day mRS scores

The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.

Time frame
90±14 days post-procedure

Secondary outcomes

1

Proportion of patients with functional independence outcome (mRS 0-2) at 90-day

modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).

Time frame
90±14 days post-procedure
2

Proportion of patients with functional independence outcome (mRS 0-1) at 90-day

modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).

Time frame
90±14 days post-procedure
3

Change in NIHSS score at 5-7 days post-procedure

Time frame
5-7 days post-procedure
4

Any mortality at 90±14 days

Primary Safety Endpoints

Time frame
90±14 days post-procedure

Other outcomes

Sponsors and contacts

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