Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

NCT07760922 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: TAMIS
• Study Type: interventional
• Target: 1,168
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (2)

• 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.

  At 90 days after randomization

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

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

  48 (±12) hours after randomization

Secondary Outcomes (9)

• mRS score at 90 days (ordinal shift analysis)

  At 90 days after randomization

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

  At 90 days after randomization

• Early neurologic deterioration (END) within 7 ± 1 days

  Within 7 ± 1 days after randomization

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

  Discharge or discharge-day 6 (±1)

• EQ-5D-5L at 90 days

  At 90 days after randomization

Study Arms (2)

Tirofiban + Aspirin

EXPERIMENTAL

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

Placebo + Aspirin

PLACEBO COMPARATOR

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

Interventions

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 + Aspirin

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.

Placebo + Aspirin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (5)

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570000, China

Location

The First People's Hospital of Jingdezhen City

Jingdezhen, Jiangxi, 341000, China

Location

The First People's Hospital of Jiujiang City

Jiujiang, Jiangxi, 341000, China

Location

The First Affiliated Hospital of Gannan Medical University

Nanchang, Jiangxi, 341000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 341000, China

Location

Related Publications (2)

• Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.

  PMID: 38648030 BACKGROUND

• Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.

  PMID: 37256974 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Zhongming Qiu

  Xinqiao Hospital of the Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daojun Hong, MD

CONTACT

+8613879187691; hongdaojun@hotmail.com

Jing Lin, MD

CONTACT

linjingsys2016@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Related papers published 6 months later, the IPD will be shared
• Access Criteria: hongdaojun@hotmail.com

Locations

CN (5)