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NCT07095790RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
580 (estimated)
First submitted
13 Jul 2025
Start date
30 Aug 2025
Primary completion date
28 Feb 2027
Lead sponsor
Second Affiliated Hospital of Soochow University
Diseases
Stroke
NCT number
NCT07095790

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 580
  • From 30 Aug 2025 to the primary completion date, 28 Feb 2027
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
  • Major surgery within 14 days.

Other illness

  • Intracranial hemorrhage confirmed by imaging.
  • Pre-stroke modified Rankin Scale (mRS) score ≥2.
  • History of primary intracerebral hemorrhage.
  • History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
  • Major systemic bleeding within 30 days.
  • Known allergy or contraindication to tirofiban or aspirin.
  • Any terminal illness with life expectancy \<6 months.

Lab values

  • 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%.
  • 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.
  • Baseline platelet count \<100 × 10⁹/L.
  • Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]).

Other

  • Untreated or inadequately treated intracranial aneurysm or vascular malformation.
  • Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment.
  • Current pregnancy or lactation.
  • Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).

Who the study is looking for

  • Age: 18-80 years old.
  • Acute mild non-cardioembolic stroke.
  • NIHSS score ≤5.
  • 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.
  • The investigational drug can be administered within 48 hours of symptom onset.
  • Signed informed consent by the patient or legally authorized representative.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
WuYuan County People's Hospital
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Bayan NurChinaRecruiting
Huai'an First People's Hospital
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Huai'anChinaRecruiting
Second Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Jiangsu Province (Suqian)Hospital
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SuqianChinaRecruiting
Zhangjiagang Hospital of Traditional Chinese Medicine
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SuzhouChinaRecruiting
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
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SuzhouChinaRecruiting
First People's Hospital of Kunshan
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SuzhouChinaRecruiting
Changshu No.1 People's Hospital
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SuzhouChinaRecruiting
Suzhou Municipal Hospital of Anhui Province
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SuzhouChinaRecruiting
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
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SuzhouChinaRecruiting
Suzhou Ninth People's Hospital
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SuzhouChinaRecruiting
Suzhou Xiangcheng People's Hospital
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SuzhouChinaRecruiting
Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Taixing Second People's Hospital
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TaizhouChinaRecruiting
Second Hospital of Tianjin Medical University
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TianjinChinaRecruiting
Nuclear Industry 417 Hospital
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Xi'anChinaRecruiting
First People's Hospital of Xianyang
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XianyangChinaRecruiting
Taikang Xian People's Hospital
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ZhoukouChinaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.