Status:
NOT_YET_RECRUITING
Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke
Lead Sponsor:
Capital Medical University
Conditions:
Acute Stroke
Ischemic Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA), administered within 4.5 hours of symptom onset, remains the standard treatment strategy for acute ischemic stroke. Howev...
Eligibility Criteria
Inclusion
- 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%)
- Informed consent obtained from patients or their acceptable surrogates.
Exclusion
- 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.
- Definite anticipation of developing indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state).
- Use of antiplatelet or anticoagulant therapy within one week pre-stroke.
- Pre-stroke mRS score ≥ 2.
- Severe consciousness disturbance with NIHSS item 1a (level of consciousness) \>1 point at randomization.
- History of tirofiban allergy or its solvents.
- History of platelet count \< 100 × 109/L caused by tirofiban.
- Major surgical operation within 6 weeks.
- Major systemic hemorrhage within 30 days;
- Determined coagulation disorders, platelet dysfunction, or platelet count \< 100\*109/L.
- Currently pregnant or lactating;
- Uncontrolled hypertension with systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg.
- Acute pericarditis or hemorrhagic retinopathy.
- Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \< 30 ml/min or serum Cr \> 220 μmol/L (2.5 mg/dl)), severe hepatic insufficiency (serum ALT \> 2 times the upper limit of normal, or serum AST \> 2 times the upper limit of normal), severe heart failure (NYHA class III or IV).
- Severe non-cardiovascular complications with an expected survival of less than 6 months.
- Unavailability for follow-up.
- Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
- Participated in this study in the past.
- Current participation in another therapeutic study with ongoing treatment and follow-up.
- Other conditions that are not suitable for participation in this study as determined by the investigator.
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT06587347
Start Date
November 20 2024
End Date
June 30 2026
Last Update
October 29 2024
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053