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

Inclusion Criteria:

• Age ≥ 18 and ≤ 90 years
• Acute ischemic stroke (AIS)
• Onset of AIS 6-24 hrs.
• NIHSS score ≥ 6
• AIS due to LVO
• core infarct <30cc or ASPECT score > 6.
• Received MT per SOC
• TICI score of 2B, or TC post MT.
• Able to be imaged by MRI
• Patient or their Legally Authorized Representative (LAR) has provided written informed consent.

Exclusion Criteria:

• Known allergy or hypersensitivity to tirofiban
• Previous stroke in the past 90 days
• Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
• Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
• Surgery or biopsy of parenchymal organ in the past 30 days
• Trauma with internal injuries or ulcerative wounds in the past 30 days
• Severe head trauma in the past 90 days
• Systolic blood pressure persistently >180mmHg post-MT despite antihypertensive intervention.
• Diastolic blood pressure persistently >105mmHg post-MT despite antihypertensive intervention.
• Serious systemic hemorrhage in the past 30 days.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >1.5
• Positive urine pregnancy test for women of childbearing potential
• Glucose <50 or >400 mg/dl
• Platelets <100,000/mm3
• Hematocrit <25 %
• Elevated PTT above laboratory upper limit of normal
• Creatinine > 4 mg/dl
• Ongoing renal dialysis, regardless of creatinine
• Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours
• Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)
• Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours
• Received iv tPA
• Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score >3
• Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if tirofiban therapy was initiated a. Example: known cirrhosis or clinically significant hepatic disease
• Current participation in another research drug treatment or interventional device trial
• Informed consent from the patient or the legally authorized representative was not or could not be obtained
• High density lesion consistent with hemorrhage of any degree
• ASPECT score < 6
• Deployment of a stent INTRA and/or EXTRA-cranial
• Did not receive MT
• TICI score of 3 post MT
• Extravasation of contrast during procedure
• Perforation of any vessel during procedure.
• Renal dysfunction
• History of gastrointestinal hemorrhage or major systemic hemorrhage within 30 days, hemoglobin less than 8 g/dL on admission, INR ≥1.5, severe liver impairment as defined as AST, ALT, AP, GGT > 2 x normal
• Creatinine clearance <30 mL/min.
• Major surgery within 30 days with contra-indication to antiplatelet therapy
• Currently pregnant.
• Contraindication for MRI

• Contra-indication to antiplatelet tirofiban:

  1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days
  2. History of thrombocytopenia following prior exposure to AGGRASTAT
  3. History, symptoms, or findings suggestive of aortic dissection
  4. Acute pericarditis
• Actual Body Weight >150kg (due to the lack of safety data)