Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

NCT07095790 | Recruiting Phase 4 DMC

• 2 other identifiers: LK20250632024yb48
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Mild Stroke

Keywords

Tirofiban; Dual Antiplatelet Therapy; Mild Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of excellent functional outcomes (mRS 0-1)

  The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death)

  90 days

Secondary Outcomes (10)

• Incidence of early neurological deterioration

  72 hours

• Incidence of early neurological improvement

  72 hours

• Change in National Institutes of Health Stroke Scale score from baseline

  7 days

• Proportion of good functional outcomes (mRS 0-2)

  90 days

• Distribution of mRS scores

  90 days

Study Arms (2)

Tirofiban+Oral Dual Antiplatelet Therapy

EXPERIMENTAL

Patients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter

Drug: Tirofiban+Oral Dual Antiplatelet Therapy

oral dual antiplatelet therapy

ACTIVE COMPARATOR

Patients will receive oral dual antiplatelet therapy alone

Drug: Oral Dual Antiplatelet Therapy

Interventions

Tirofiban+Oral Dual Antiplatelet Therapy DRUG

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)

Also known as: Tirofiban with Sequential Dual Antiplatelet Therapy

Tirofiban+Oral Dual Antiplatelet Therapy

Oral Dual Antiplatelet Therapy DRUG

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

Also known as: Dual Antiplatelet Therapy, Aspirin plus Clopidogrel

oral dual antiplatelet therapy

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 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.

You may not qualify if:

• Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
• Intracranial hemorrhage confirmed by imaging.
• Pre-stroke modified Rankin Scale (mRS) score ≥2.
• 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%.
• History of primary intracerebral hemorrhage.
• History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
• Untreated or inadequately treated intracranial aneurysm or vascular malformation.
• Major systemic bleeding within 30 days.
• 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.
• Major surgery within 14 days.
• Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment.
• Baseline platelet count \<100 × 10⁹/L.
• Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]).
• Known allergy or contraindication to tirofiban or aspirin.
• Current pregnancy or lactation.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (18)

Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, China

RECRUITING

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Taikang Xian People's Hospital

Zhoukou, Henan, China

RECRUITING

WuYuan County People's Hospital

Bayan Nur, Inner Mongolia, China

RECRUITING

Huai'an First People's Hospital

Huai'an, Jiangsu, China

RECRUITING

Jiangsu Province (Suqian) Hospital

Suqian, Jiangsu, China

RECRUITING

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

RECRUITING

Affiliated Jiangsu Shengze Hospital of Nanjing Medical University

Suzhou, Jiangsu, China

RECRUITING

Changshu No.1 People's Hospital

Suzhou, Jiangsu, China

RECRUITING

First People's Hospital of Kunshan

Suzhou, Jiangsu, China

RECRUITING

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, China

RECRUITING

Suzhou Xiangcheng People's Hospital

Suzhou, Jiangsu, China

RECRUITING

Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine

Suzhou, Jiangsu, China

RECRUITING

Zhangjiagang Hospital of Traditional Chinese Medicine

Suzhou, Jiangsu, China

RECRUITING

Taixing Second People's Hospital

Taizhou, Jiangsu, China

RECRUITING

Nuclear Industry 417 Hospital

Xi'an, Shaanxi, China

RECRUITING

First People's Hospital of Xianyang

Xianyang, Shaanxi, China

RECRUITING

Second Hospital of Tianjin Medical University

Tianjin, China

RECRUITING

MeSH Terms

Interventions

Tirofiban; Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jijun Shi, M.D

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jijun Shi, M.D

CONTACT

+86 512 67783689; shijijun2008@126.com

Yongjun Cao, M.D, PhD

CONTACT

yongjuncao@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 31, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)