Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke.

Eligibility criteria

Qualifiers

Age ≥18 years old;

Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.

Residual NIHSS score ≥ 5 points at randomization (at least 1 hour after intravenous thrombolytic therapy).

Post-thrombolysis imaging shows that the offending artery is consistent with moderate or severe intracranial atherosclerotic stenosis (within 50%~99%)

Disqualifiers

Intracranial hemorrhage confirmed by imaging post-thrombolysis.

Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.

Scheduled for or received endovascular treatment after onset.

Definite or suspected cardioembolic stroke.

Trial design

Treatments tested in this trial

  • Tirofiban Hydrochloride
  • Standard medical treatment (SMT)

Treatment groups

302 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Capital Medical University

Lead sponsor

Xuanwu Hospital, Beijing

Sponsor institution