Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

Phase 4Not Yet RecruitingNCT07760922

Xinqiao Hospital of Chongqing1,168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,168

Conditions

Ischemic Stroke, Acute

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-80 years; 2. Acute ischemic stroke; time from last known well to randomization ≤ 24 hours; 3. Pre-randomization NIHSS score 4-10, with at least one of item 5 (upper limb) or item 6 (lower limb) ≥ 1; 4. Pre-stroke modified Rankin Scale (mRS) ≤ 1; 5. Written informed consent provided by the patient or a legally authorized representative. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT or MRI; 2. Has received or is planned to receive reperfusion therapy (thrombolysis or endovascular treatment); 3. 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%; 4. Definite indication for anticoagulation (atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism); 5. Severe systemic disease (e.g., severe infection, severe hepatic or renal dysfunction); 6. Allergy to tirofiban and/or aspirin; 7. History of intracranial hemorrhage; 8. Planned use of NSAIDs affecting platelet function; 9. Gastrointestinal bleeding or major surgery within the past 3 months; 10. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months; 11. Planned surgery or intervention requiring discontinuation of antiplatelet therapy; 12. Stroke caused by angiography or surgery; 13. Prior non-atherosclerotic arterial disease, including moyamoya disease, arterial dissection, fibromuscular dysplasia; 14. Other structural brain disease (vascular malformation, tumor, abscess, multiple sclerosis, etc.) confirmed by CT/MRI; 15. Pregnancy or lactation; 16. Prior neurologic or psychiatric disease that would interfere with neurologic assessment; 17. Participation in another clinical trial; 18. Advanced disease with expected survival \< 6 months; 19. Expected inability to complete follow-up.

Locations (5)

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The First People's Hospital of Jingdezhen City

Jingdezhen, Jiangxi, China

The First People's Hospital of Jiujiang City

Jiujiang, Jiangxi, China

The First Affiliated Hospital of Gannan Medical University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Outcomes

Primary Outcomes

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) (%)

Time frame: 48 (±12) hours after randomization

Secondary Outcomes

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

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)

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

EQ-5D-5L at 90 days

Time frame: At 90 days after randomization

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

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

90-day all-cause mortality

Time frame: At 90 days after randomization

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

Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts