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NCT Number: NCT07760922

Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Hainan Medical University, Haikou, Hainan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years;
  • Acute ischemic stroke; time from last known well to randomization ≤ 24 hours;
  • Pre-randomization NIHSS score 4-10, with at least one of item 5 (upper limb) or item 6 (lower limb) ≥ 1;
  • Pre-stroke modified Rankin Scale (mRS) ≤ 1;
  • Written informed consent provided by the patient or a legally authorized representative.

Exclusion criteria

  • Intracranial hemorrhage confirmed by CT or MRI;
  • Has received or is planned to receive reperfusion therapy (thrombolysis or endovascular treatment);
  • Any definite cardioembolic source: chronic/paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction < 30%;
  • Definite indication for anticoagulation (atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism);
  • Severe systemic disease (e.g., severe infection, severe hepatic or renal dysfunction);
  • Allergy to tirofiban and/or aspirin;
  • History of intracranial hemorrhage;
  • Planned use of NSAIDs affecting platelet function;
  • Gastrointestinal bleeding or major surgery within the past 3 months;
  • Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months;
  • Planned surgery or intervention requiring discontinuation of antiplatelet therapy;
  • Stroke caused by angiography or surgery;
  • Prior non-atherosclerotic arterial disease, including moyamoya disease, arterial dissection, fibromuscular dysplasia;
  • Other structural brain disease (vascular malformation, tumor, abscess, multiple sclerosis, etc.) confirmed by CT/MRI;
  • Pregnancy or lactation;
  • Prior neurologic or psychiatric disease that would interfere with neurologic assessment;
  • Participation in another clinical trial;
  • Advanced disease with expected survival < 6 months;
  • Expected inability to complete follow-up.

Treatment and study plan

tirofiban

Drug

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.

Tirofiban-matching placebo

Drug

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.

Primary outcomes

  1. Proportion of patients with mRS 0-1 at 90 days (%)

    Time frame: At 90 days after randomization

    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.

  2. Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)

    Time frame: 48 (±12) hours after randomization

    Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)

Secondary outcomes

  1. mRS score at 90 days (ordinal shift analysis)

    Time frame: At 90 days after randomization

    mRS score at 90 days (ordinal shift analysis)

  2. Proportion with functional independence (mRS 0-2) at 90 days

    Time frame: At 90 days after randomization

    Proportion with functional independence (mRS 0-2) at 90 days

  3. Early neurologic deterioration (END) within 7 ± 1 days

    Time frame: Within 7 ± 1 days after randomization

    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.

  4. Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)

    Time frame: Discharge or discharge-day 6 (±1)

    Change in NIHSS from pre-randomization to discharge or discharge-day 6 (±1)

  5. EQ-5D-5L at 90 days

    Time frame: At 90 days after randomization

    EQ-5D-5L at 90 days

  6. Any intracranial hemorrhage on imaging within 48 (±12) hours

    Time frame: Within 48 (±12) hours after randomization

    Any intracranial hemorrhage on imaging within 48 (±12) hours

  7. 90-day all-cause mortality

    Time frame: At 90 days after randomization

    90-day all-cause mortality

  8. Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)

    Time frame: Within 48 (±12) hours after randomization

    Major extracranial bleeding within 48 (±12) hours (GUSTO moderate and severe)

  9. Non-hemorrhagic serious adverse event rate

    Time frame: Within 90 days after randomization

    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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Daojun Hong, MD

CONTACT

[email protected]

+8613879187691

Jing Lin, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

  • The First Affiliated Hospital of Nanchang University

Registry information

Official study title

Efficacy and Safety of Tirofiban Combined With Aspirin in Moderate Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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