Actively Recruiting
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
Led by Beijing Tiantan Hospital · Updated on 2024-07-12
4674
Participants Needed
5
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, double-blind, double-dummy, randomized clinical trial comparing the efficacy and safety of tirofiban versus placebo in preventing recurrence of stroke for patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events.
CONDITIONS
Official Title
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years or older
- Acute non-disabling ischemic stroke with NIHSS score 5 or less at randomization, or TIA with ABCD2 score 6 or higher at randomization
- Symptomatic intracranial artery stenosis of 50% or more in the infarcted artery confirmed by MRA, CTA, or DSA
- Able to receive study drug within 24 hours of symptom onset
- Signed informed consent
You will not qualify if you...
- Major non-ischemic brain disease such as malformation, tumor, abscess, or multiple sclerosis on baseline imaging
- Unable to evaluate intracranial artery stenosis before randomization
- Isolated sensory symptoms, visual changes, or dizziness without acute infarction evidence
- Stroke or TIA caused by angioplasty or surgery
- Modified Rankin scale score greater than 2 before symptom onset
- Contraindications to tirofiban including allergy, severe kidney or liver problems, severe heart failure, bleeding disorders, low blood cell counts
- Use of tirofiban since symptom onset
- Hematocrit below 30%
- Clear need for anticoagulation such as atrial fibrillation or prosthetic valves
- History of intracranial hemorrhage or amyloid angiopathy
- History of aneurysm
- History of asthma or COPD
- High risk for slow heart rhythm conditions without pacemaker
- Planned revascularization or surgery within 3 months requiring stopping study drug
- Severe non-cardiovascular illness with life expectancy under 3 months
- Mental, cognitive, or emotional disorders preventing understanding or following study
- Use of heparin or oral anticoagulants within 10 days before randomization
- Thrombolytic therapy or mechanical thrombectomy within 24 hours before randomization
- Large brain area damage on baseline CT scan
- Recent gastrointestinal bleeding or major surgery
- Suspected acute coronary syndrome
- Participation in another experimental study within 30 days
- Current treatment with experimental drugs or devices
- Pregnant, trying to become pregnant, or not using birth control if of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086
Actively Recruiting
2
People's Hospital of Qihe County
Dezhou, Shandong, China, 251199
Actively Recruiting
3
Liaocheng People's Hospital（Liaocheng Brain Hospital）
Liaocheng, Shandong, China, 252001
Actively Recruiting
4
Third People's Hospital of Liaocheng
Liaocheng, Shandong, China, 252004
Actively Recruiting
5
Yantai Penglai traditional Chinese medicine hospital
Yantai, Shandong, China, 265699
Actively Recruiting
Research Team
Y
Yongjun Wang
CONTACT
J
Jing Jing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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