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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial

Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke (NCT07095790) is a Phase 4 interventional studying Mild Stroke, sponsored by Second Affiliated Hospital of Soochow University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 580 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age: 18-80 years old. 2. Acute mild non-cardioembolic stroke. 3. NIHSS score ≤5. 4. Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours. 5. The investigational drug can be administered within 48 hours of symptom onset. 6. Signed willing to sign a consent form by the patient or legally authorized representative. Who Should NOT Join This Trial: 1. Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment) 2. Intracranial hemorrhage confirmed by imaging. 3. Pre-stroke modified Rankin Scale (mRS) score ≥2. 4. Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \<30%. 5. History of primary intracerebral hemorrhage. 6. History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage). 7. Untreated or inadequately treated intracranial aneurysm or vascular malformation. 8. Major systemic bleeding within 30 days. 9. Active bleeding, including laboratory evidence of coagulopathy (platelet count \<100 × 10⁹/L, activated partial thromboplastin time \>50 seconds, or international normalized ratio \>1.7), or treatment with direct oral anticoagulants within the preceding 48 hours. 10. Major surgery within 14 days. 11. Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment. 12. Baseline platelet count \<100 × 10⁹/L. 13. Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]). 14. Known allergy or contraindication to tirofiban or aspirin. 15. Current pregnancy or lactation. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age: 18-80 years old. 2. Acute mild non-cardioembolic stroke. 3. NIHSS score ≤5. 4. Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours. 5. The investigational drug can be administered within 48 hours of symptom onset. 6. Signed informed consent by the patient or legally authorized representative. Exclusion Criteria: 1. Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment) 2. Intracranial hemorrhage confirmed by imaging. 3. Pre-stroke modified Rankin Scale (mRS) score ≥2. 4. Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \<30%. 5. History of primary intracerebral hemorrhage. 6. History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage). 7. Untreated or inadequately treated intracranial aneurysm or vascular malformation. 8. Major systemic bleeding within 30 days. 9. Active bleeding, including laboratory evidence of coagulopathy (platelet count \<100 × 10⁹/L, activated partial thromboplastin time \>50 seconds, or international normalized ratio \>1.7), or treatment with direct oral anticoagulants within the preceding 48 hours. 10. Major surgery within 14 days. 11. Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment. 12. Baseline platelet count \<100 × 10⁹/L. 13. Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]). 14. Known allergy or contraindication to tirofiban or aspirin. 15. Current pregnancy or lactation. 16. Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter). 17. Any terminal illness with life expectancy \<6 months.

Treatments Being Tested

DRUG

Tirofiban+Oral Dual Antiplatelet Therapy

Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 47.5 hours; sequential Oral Dual Antiplatelet Therapy (Aspirin 100mg qd; Clopidogrel 75mg qd)

DRUG

Oral Dual Antiplatelet Therapy

Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, China
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Taikang Xian People's Hospital
Zhoukou, Henan, China
WuYuan County People's Hospital
Bayan Nur, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province (Suqian) Hospital
Suqian, Jiangsu, China
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
Suzhou, Jiangsu, China
Changshu No.1 People's Hospital
Suzhou, Jiangsu, China
First People's Hospital of Kunshan
Suzhou, Jiangsu, China
Suzhou Ninth People's Hospital
Suzhou, Jiangsu, China
Suzhou Xiangcheng People's Hospital
Suzhou, Jiangsu, China
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu, China
Zhangjiagang Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
Taixing Second People's Hospital
Taizhou, Jiangsu, China
Nuclear Industry 417 Hospital
Xi'an, Shaanxi, China
First People's Hospital of Xianyang
Xianyang, Shaanxi, China
Second Hospital of Tianjin Medical University
Tianjin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07095790), the sponsor (Second Affiliated Hospital of Soochow University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07095790 clinical trial studying?

This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07095790?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07095790?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07095790. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07095790. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.