A Phase 3 interventional study of Tirofiban and dual antiplatelet therapy in Stroke, Acute, Stroke, Ischemic and Cerebral Infarction, sponsored by Weifang Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Weifang Medical University · Phase 3, Interventional, and Treatment
This study aims to address the existing clinical challenges by introducing high-resolution magnetic resonance vessel wall imaging (HR-MRI), an advanced imaging technology, to achieve precise etiological classification in patients with acute ischemic stroke (AIS) beyond the time window. HR-MRI allows clear visualization of intracranial arterial wall structures and direct identification of key pathological features of the culprit vessel, including atherosclerotic plaques, vascular wall remodeling, and intracranial hemorrhage, thereby enabling reliable differentiation between intracranial atherosclerotic large artery atherosclerosis (ICAS-LAA) stroke and other etiological subtypes such as cardiogenic embolism. Based on the latest clinical demands and advances in imaging technology, this study intends to evaluate the efficacy and safety of tirofiban in patients with ICAS-LAA stroke beyond the time window under the precise guidance of HR-MRI. It is expected to provide high-level evidence-based medical evidence for this specific patient population and further optimize clinical diagnosis and treatment strategies.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 458 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Weifang Medical University is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients were randomized to the Tirofiban Combined with Dual Antiplatelet Therapy Group. Intravenous tirofiban was administered within 30 minutes of randomization, with an initial bolus infusion at a rate of 0.4 μg/(kg·min) for 30 minutes, followed by a continuous infusion at 0.1 μg/(kg·min) for 47.5 hours. During this period, dual antiplatelet therapy (DAPT) was initiated at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day, with an overlapping duration of 4-6 hours. After the completion of tirofiban infusion, dual antiplatelet therapy (aspirin 100 mg/day plus clopidogrel 75 mg/day) was continued for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
Drug: Tirofiban · Drug: dual antiplatelet therapy
Patients were randomized to the control group, with dual antiplatelet therapy (DAPT) initiated as early as possible at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
Drug: dual antiplatelet therapy
Intravenous tirofiban was administered within 30 minutes of randomization, with an initial bolus infusion at a rate of 0.4 μg/(kg·min) for 30 minutes, followed by a continuous infusion at 0.1 μg/(kg·min) for 47.5 hours.
Initiate dual antiplatelet therapy as early as possible (aspirin 100 mg/day plus clopidogrel 75 mg/day) for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone. For patients at high risk of stroke, such as those with severe stenosis of major blood vessels, dual antiplatelet therapy should be administered for 90 days.
Also known as: aspirin, clopidogrel
Proportion of participants with functional independence outcome [modified Rankin Scale(mRS) score 0-1]
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death); a lower score indicates a better prognosis.
Time frame: 90 ± 7 days after randomization
Proportion of participants with good prognosis (mRS score 0-2)
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death);a lower score indicates a better prognosis.
Time frame: 90 ± 7 days after randomization
Proportion of participants with mRS score 0-3
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death);a lower score indicates a better prognosis.
Time frame: 90 ± 7 days after randomization
Distribution of mRS scores
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death);a lower score indicates a better prognosis.
Time frame: 90 ± 7 days after randomization
EuroQol Five-Dimension Questionnaire (EQ-5D) score
The EQ-5D is a standardized patient-reported outcome measure for evaluating health-related quality of life (HRQoL), consisting of the EQ-5D descriptive system (assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ visual analog scale (EQ-VAS). The utility score derived from the descriptive system will be adopted for statistical analysis, with a range of -0.594 to 1.0 based on the applicable value set. A higher score indicates better health-related quality of life: a score of 1.0 represents perfect health, 0 equates to a health state equivalent to death, and negative scores reflect health states worse than death. The EQ-VAS (0-100 scale, 0 = worst imaginable health state; 100 = best imaginable health state) will be analyzed as a supplementary index.
Time frame: 90 ± 7 days after randomization
Barthel Index (BI) score
the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
Time frame: 90 ± 7 days after randomization
Proportion of participants with neurological improvement within 24 hours of randomization [≥2-point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline]
the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);
Time frame: 24 ± 6 hours
National Institutes of Health Stroke Scale (NIHSS) scores
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)
Time frame: Time Frame: 24h; before discharge; day7
Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization
clinical safety endpoint
Time frame: 24 ± 6 hours
Early neurological deterioration(END)
defined as NIHSS score increased by #4 points within 24 hours
Time frame: 24 ± 6 hours
Incidence of serious adverse events (SAEs)
clinical safety endpoint
Time frame: 24 ± 6 hours;
Incidence of any adverse events
clinical safety endpoint
Time frame: 24 ± 6 hours;
Recurrent stroke
clinical safety endpoint;the new neurological deficit must be accompanied by corresponding new ischemic or hemorrhagic lesions on brain CT or MRI, which are not contiguous with the index stroke lesion and do not correspond to the vascular territory of the index stroke.
Time frame: 90 ± 7 days after randomization
all-cause mortality;
clinical safety endpoint; to observe the proportion of all patients who died in each group
Time frame: 90 ± 7 days after randomization
stroke-related mortality
clinical safety endpoint;The proportion of stroke related deaths in each group
Time frame: 90 ± 7 days after randomization
Proportion of participants with any intracranial hemorrhage
imaging safety endpoints; to observe the proportion of intracranial hemorrhage patients in each group
Time frame: 24 ± 6 hours
Started Jun 2026 (actual). Primary completion is estimated for Feb 2029, 31 months after the start.
Of 92 non-industry phase 3 interventional studies under Stroke, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 31 months is below that.
Counting every sponsor, half of 129 studies reached it within 44 months; a quarter within 27 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tirofiban
Weifang Medical University