Phase
Condition
Stroke
Thrombosis
Blood Clots
Treatment
Intravenous thrombolysis plus tirofiban
Intravenous thrombolysis plus placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Onset of ischemic stroke symptoms within ≤ 4.5 hours*, treated with intravenousrt-PA or TNK according to guidelines;
NIHSS score of 4-25 before intravenous thrombolysis;
Age ≥ 18 years;
Able to receive the designated study drug within 60 minutes after intravenousthrombolysis;
Informed consent signed by the patient or their legal representative. *Symptom onsetis defined as the last known well time.
Exclusion
Exclusion Criteria:
Presence of contraindications to intravenous thrombolysis;
Pre-stroke mRS score > 1;
Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);
Patients with a history of atrial fibrillation or emergency ECG indicating atrialfibrillation;
Pregnant or lactating women;
NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS < 6;
If NIHSS worsens by 2 or more points between start of thrombolysis and start ofstudy drug, repeat brain imaging rules out new intracranial hemorrhage;
Severe leukoaraiosis;
Currently participating in other clinical trials;
Known genetic or acquired bleeding diathesis, or received warfarin and INR > 1.7; ortreated with direct oral anticoagulant agents in the prior 48 hours;
Severe renal failure, defined as serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) orglomerular filtration rate [GFR] < 30, or patients requiring hemodialysis orperitoneal dialysis;
Liver dysfunction (ALT > 2 times the upper limit of normal or AST > 2 times theupper limit of normal);
Known allergy to tirofiban or other IIb/IIIa inhibitors;
Life expectancy < 1 year;
Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients,etc.).
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui 230001
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.