Clinical Trial to Evaluate the Safety of Continuous IV Tirofiban in Acute Ischemic Stroke

Summary

Participation Requirements

Description

Procedures: Potential subject present with acute ischemic changes to our Emergency department (ED) and evaluated by stroke neurologist. If the potential subject is a candidate for MT then the patient will be screened for inclusions / exclusions criteria. Patient will undergo MT per standard of care ...

Procedures: Potential subject present with acute ischemic changes to our Emergency department (ED) and evaluated by stroke neurologist. If the potential subject is a candidate for MT then the patient will be screened for inclusions / exclusions criteria. Patient will undergo MT per standard of care (SOC). At the end of the procedure, the interventionist will assign a specific score for reperfusion following MT. If the interventionist assign a score of TICI 2b, then the potential subject will be eligible to be randomized if she/he meets all the other inclusion /exclusion criteria. If the potential subject has score of TICI 2b after MT and meets all the other inclusion/exclusion criteria, then the power of attorney( POA) /LAR of the potential subject will be approached and informed about the study. If the POA /LAR signs the informed consent, then the subject will be randomized to placebo vs. Tirofiban. The randomization will be 1:1 and will be done by the Investigational Drug Service (IDS) pharmacy. The informed consent must be signed within 60 min from the end of the MT. If the informed consent is obtained, then the agent (placebo or Tirofiban) will must initiated no later than 60 min from the end of the MT. The subject will be transferred to SNICU per SOC. The infusion will continue for 24 hours then stopped. At the end of the 24 hours of infusion a CTA/CTP will be obtained to assess perfusion. If the subject neurological exam deteriorates / worsen during the infusion, the medication will be stopped and unblinded. Non contrast HCT will be obtained immediately to assess if there is a new hemorrhage. If there is hemorrhage and the subject was on Tirofiban then a pack of platelet will be ordered infused immediately. If the subject is on placebo, then no need to infuse a pack of platelets. Platelet count will be assess daily for 48 hours from initiating the medication If the platelet count drops below 20,000, then the medication will be stopped immediately and unblinded. Th rest of the hospitalization will be done per SOC. The subject's NIHSS and mRS will be assessed at 90 days.

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