NCT04818944

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

A Pilot, Exploratory Clinical Trial to Evaluate the Safety of Using Continuous IV Infusion of Tirofiban (24 Hours) Including Its Efficacy in Improving Perfusion Post Mechanical Thrombectomy in Acute Ischemic Stroke

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

We will recruit men and non-pregnant women of any ethnic background between the age ≥ 18 and ≤ 90 years that have acute ischemic stroke and underwent Mechanical Thrombectomy (MT) with TICI 2b or 2b following MT. These subject's will be will be randomized to placebo vs. Tirofiban after consent is obtained. This will be administered via continuous IV starting within 60 minutes of MT procedure completion. At the end of the 24 hour continuous IV dosing period a CT angiography and CT perfusion (CTA/CTP) will be obtained. The rest of the subjects inpatient hospital stay will be done per standard of care. The subject's NIHSS and modified Rankin Score (mRS) will be assessed at 90 days.

Detailed description

Procedures: 1. Potential subject present with acute ischemic changes to our Emergency department (ED) and evaluated by stroke neurologist. 2. If the potential subject is a candidate for MT then the patient will be screened for inclusions / exclusions criteria. 3. Patient will undergo MT per standard of care (SOC). 4. At the end of the procedure, the interventionist will assign a specific score for reperfusion following MT. 5. 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. 6. 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. 7. If the POA /LAR signs the informed consent, then the subject will be randomized to placebo vs. Tirofiban. 8. The randomization will be 1:1 and will be done by the Investigational Drug Service (IDS) pharmacy. 9. The informed consent must be signed within 60 min from the end of the MT. 10. 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. 11. The subject will be transferred to SNICU per SOC. 12. The infusion will continue for 24 hours then stopped. 13. At the end of the 24 hours of infusion a CTA/CTP will be obtained to assess perfusion. 14. 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. 15. 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. 16. Platelet count will be assess daily for 48 hours from initiating the medication 17. If the platelet count drops below 20,000, then the medication will be stopped immediately and unblinded. 18. Th rest of the hospitalization will be done per SOC. 19. The subject's NIHSS and mRS will be assessed at 90 days.

Conditions

• Acute Ischemic Stroke
• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tirofiban Hydrochloride	Tirofiban Hydrochloride will be dosed for 24 hours post MT via continuous IV
DRUG	Placebo	Saline will be dosed for 24 hours post MT via continuous IV

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-01-01
• Completion: 2025-09-01
• First posted: 2021-03-26
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study