Status:
WITHDRAWN
Clinical Trial to Evaluate the Safety of Continuous IV Tirofiban in Acute Ischemic Stroke
Lead Sponsor:
University of Iowa
Conditions:
Acute Ischemic Stroke
Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief 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 fo...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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:
- Active internal bleeding or a history of bleeding diathesis within the previous 30 days
- History of thrombocytopenia following prior exposure to AGGRASTAT
- History, symptoms, or findings suggestive of aortic dissection
- Acute pericarditis
- Actual Body Weight \>150kg (due to the lack of safety data)
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04818944
Start Date
March 1 2023
End Date
September 1 2025
Last Update
September 21 2022
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242