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Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

ConditionIschemic Stroke, Acute
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXinqiao Hospital of Chongqing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,168 Participants
are divided into 2 treatment groups
Group A: Tirofiban + AspirinExperimental treatment 1 intervention
Group B: Placebo + AspirinPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

mRS score at 90 days (ordinal shift analysis)

mRS score at 90 days (ordinal shift analysis)

Time frame
At 90 days after randomization
2

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
3

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
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

The First Affiliated Hospital of Nanchang University

Collaborator

Source ClinicalTrials.gov

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