A Phase 4 interventional study of Tirofiban and Tirofiban-matching placebo in Ischemic Stroke, Acute, sponsored by Xinqiao Hospital of Chongqing. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Xinqiao Hospital of Chongqing · Phase 4, Interventional, and Treatment
Ischemic stroke accounts for the majority of stroke cases in China, and moderate ischemic stroke (NIHSS 4-10) carries a high risk of early neurologic deterioration (END) and long-term disability. Although intensified antiplatelet strategies reduce END, they have not consistently improved long-term functional outcome. Tirofiban, a selective glycoprotein IIb/IIIa receptor inhibitor, has shown a clinically meaningful trend toward better 90-day functional outcome (mRS 0-1) in prior tirofiban trials, but existing sample sizes were underpowered to detect this difference.
TAMIS is a multicenter, randomized, double-blind, placebo-controlled superiority trial in patients with acute moderate ischemic stroke (NIHSS 4-10) within 24 hours of last known well. Eligible patients are randomized 1:1 to tirofiban plus aspirin versus placebo plus aspirin, both on a background of guideline-based standard medical care. The primary efficacy endpoint is the proportion of patients with an excellent functional outcome (mRS 0-1) at 90 days. The primary safety endpoint is symptomatic intracranial hemorrhage within 48 (±12) hours by the Heidelberg criteria.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,168 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xinqiao Hospital of Chongqing is the lead sponsor of 69 studies on the registry; 21 are open to participants now.
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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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care.
Drug: Tirofiban
Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h) after randomization. Plus guideline-based standard care.
Drug: Tirofiban-matching placebo
Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care.
Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h). Plus guideline-based standard care.
Proportion of patients with mRS 0-1 at 90 days (%)
Proportion of patients achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 or 1 at 90 days after randomization.
Time frame: At 90 days after randomization
Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)
Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)
Time frame: 48 (±12) hours after randomization
mRS score at 90 days (ordinal shift analysis)
mRS score at 90 days (ordinal shift analysis)
Time frame: At 90 days after randomization
Proportion with functional independence (mRS 0-2) at 90 days
Proportion with functional independence (mRS 0-2) at 90 days
Time frame: At 90 days after randomization
Early neurologic deterioration (END) within 7 ± 1 days
Early neurologic deterioration (END) within 7 ± 1 days, defined as an increase in NIHSS ≥ 2 points within 7 days, with the hemiparesis item increasing ≥ 1 or the level-of-consciousness item increasing ≥ 1, after excluding intracranial hemorrhage or other non-stroke causes.
Time frame: Within 7 ± 1 days after randomization
Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)
Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)
Time frame: Discharge or discharge-day 6 (±1)
EQ-5D-5L at 90 days
EQ-5D-5L at 90 days
Time frame: At 90 days after randomization
Any intracranial hemorrhage on imaging within 48 (±12) hours
Any intracranial hemorrhage on imaging within 48 (±12) hours
Time frame: Within 48 (±12) hours after randomization
90-day all-cause mortality
90-day all-cause mortality
Time frame: At 90 days after randomization
Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)
Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)
Time frame: Within 48 (±12) hours after randomization
Non-hemorrhagic serious adverse event rate
Non-hemorrhagic serious adverse event rate (including cerebral hernia, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, psychiatric symptoms, etc.)
Time frame: Within 90 days after randomization
Plan to share: Yes — Study data without patient information
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Related papers published 6 months later, the IPD will be shared
Access criteria: hongdaojun@hotmail.com
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tirofiban
Xinqiao Hospital of Chongqing