Tirofiban with sequential dual antiplatelet therapy in mild acute ischemic stroke (TiMIS): protocol for a multicenter, randomized controlled trial.
Jiaping Xu, Hao Peng, Yafang Zhu...
https://pubmed.ncbi.nlm.nih.gov/41834238Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID07095790
Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
Led by Second Affiliated Hospital of Soochow University · Updated on 2025-07-31
580
Participants Needed
18
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether starting intravenous tirofiban within 48 hours after mild ischemic stroke symptoms begin, followed by dual antiplatelet therapy (DAPT), can improve functional recovery compared to standard DAPT alone. This study focuses on patients with mild stroke symptoms (NIHSS score 5 or less) who often face risks of early neurological decline and poor outcomes despite current treatments. The trial aims to provide more evidence on tirofiban's potential benefits in this group. Participants are randomly assigned to one of two groups: one receiving an initial intravenous tirofiban infusion for 48 hours with a specific dosing schedule, then switching to oral dual antiplatelet therapy (aspirin and clopidogrel), and the other receiving standard oral dual antiplatelet therapy alone. The trial is open-label with blinded outcome assessment and compares the treatments over the early period following stroke onset. Throughout the study, participants will be monitored for functional outcomes using the modified Rankin Scale at 90 days. Additional assessments include neurological status changes within the first 7 days, stroke recurrence, bleeding events, and cardiovascular outcomes. The trial lasts through 90 days after treatment start, with careful safety and effectiveness evaluations to understand the impact of the treatment approach.
CONDITIONS
Brief Title
Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Acute mild non-cardioembolic ischemic stroke
- NIHSS score of 5 or less
- Time from stroke onset (or last known well time) to randomization within 48 hours
- Able to receive study drug within 48 hours of symptom onset
- Signed informed consent by patient or legally authorized representative
You will not qualify if you...
- Received or planned intravenous thrombolysis or bridging therapy
- Intracranial hemorrhage confirmed by imaging
- Pre-stroke modified Rankin Scale score of 2 or higher
- Confirmed cardioembolic source or recent myocardial infarction
- History of primary intracerebral hemorrhage or other intracranial bleeding
- Untreated or inadequately treated intracranial aneurysm or vascular malformation
- Major systemic bleeding within 30 days
- Active bleeding or coagulopathy or recent use of direct oral anticoagulants
- Major surgery within 14 days
- Persistently elevated blood pressure despite treatment
- Baseline platelet count below 100 x 10⁹/L
- Severe renal dysfunction
- Known allergy or contraindication to tirofiban or aspirin
- Current pregnancy or lactation
- Any intracranial tumor except small asymptomatic meningiomas
- Terminal illness with life expectancy under 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 48 hours for tirofiban infusion followed by continued oral dual antiplatelet therapy up to 90 days
Participants receive either a 48-hour intravenous tirofiban infusion followed by oral dual antiplatelet therapy, or oral dual antiplatelet therapy alone.
1 baseline visit and multiple follow-up visits during treatment
Follow-up
Duration - Up to 90 days
Participants are monitored for functional outcomes and adverse events up to 90 days after starting treatment.
Approximately 3 visits during follow-up
Trial Site Locations
Total: 18 locations
1
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, China
Actively Recruiting
2
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
3
Taikang Xian People's Hospital
Zhoukou, Henan, China
Actively Recruiting
4
WuYuan County People's Hospital
Bayan Nur, Inner Mongolia, China
Actively Recruiting
5
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Actively Recruiting
6
Jiangsu Province (Suqian) Hospital
Suqian, Jiangsu, China
Actively Recruiting
7
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Actively Recruiting
8
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
Suzhou, Jiangsu, China
Actively Recruiting
9
Changshu No.1 People's Hospital
Suzhou, Jiangsu, China
Actively Recruiting
10
First People's Hospital of Kunshan
Suzhou, Jiangsu, China
Actively Recruiting
11
Suzhou Ninth People's Hospital
Suzhou, Jiangsu, China
Actively Recruiting
12
Suzhou Xiangcheng People's Hospital
Suzhou, Jiangsu, China
Actively Recruiting
13
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu, China
Actively Recruiting
14
Zhangjiagang Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
Actively Recruiting
15
Taixing Second People's Hospital
Taizhou, Jiangsu, China
Actively Recruiting
16
Nuclear Industry 417 Hospital
Xi'an, Shaanxi, China
Actively Recruiting
17
First People's Hospital of Xianyang
Xianyang, Shaanxi, China
Actively Recruiting
18
Second Hospital of Tianjin Medical University
Tianjin, China
Actively Recruiting
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Research Team
J
Jijun Shi, M.D
Y
Yongjun Cao, M.D, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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