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New treatment option for Ischemic Stroke, Acute
Official title Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
ClinicalTrials.gov ID: NCT06319846
What this study is testing
What is Tirofiban?
Tirofiban is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic stroke, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 40 years or older than 40 years;
- Acute cerebral ischemic event due to:
- Acute non-disabling ischemic stroke (NIHSS≤5 at the time of randomization) or,
- TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 6 at the time of randomization);
- Accompanied with symptomatic intracranial artery stenosis, defined as ≥ 50% stenosis of the infarcted ipsilateral intracranial artery. Intracranial...
You likely can't join if
- Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
- Unable to complete the evaluation of intracranial artery stenosis before randomization.
- Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on...
- Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA.
- A score of \> 2 on the modified Rankin scale before the symptom onset.
- Contraindication for tirofiban:
See the full eligibility criteria
- 40 years or older than 40 years;
- Acute cerebral ischemic event due to:
- Acute non-disabling ischemic stroke (NIHSS≤5 at the time of randomization) or,
- TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 6 at the time of randomization);
- Accompanied with symptomatic intracranial artery stenosis, defined as ≥ 50% stenosis of the infarcted ipsilateral intracranial artery. Intracranial arteries include intracranial segments of internal carotid arteries...
- Can be treated with study drug within 24 hours of symptoms onset\ (\ Symptom onset is defined by the "last seen normal" principle);
- Informed consent signed.
- Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
- Unable to complete the evaluation of intracranial artery stenosis before randomization.
- Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
- Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA.
- A score of \> 2 on the modified Rankin scale before the symptom onset.
- Contraindication for tirofiban:
- Known allergy
- Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST \> twice the upper limit of normal range) insufficiency
- Severe cardiac failure (NYHA level: III to IV)
- History of hemostatic disorder or systemic bleeding
- History of thrombocytopenia or neutropenia
- History of drug-induced hematologic disorder or hepatic dysfunction
- Low white blood cell (\<2×109/L) or platelet count (\<100×109/L)
- Tirofiban has been used since this onset.
- Hematocrit (HCT) \<30%.
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
- History of intracranial hemorrhage or amyloid angiopathy.
- History of aneurysm (including intracranial aneurysm and peripheral aneurysm).
- History of asthma or COPD (chronic obstructive pulmonary disease).
- High-risk for bradyarrhythmia (sinus node disease, first-degree or second-degree AV block, and brady-arrhythmic syncope without pacemaker).
- Planned or likely revascularization (any angioplasty or endovascular surgery) within the next 3 months.
- Scheduled for surgery or treatment treatment requiring study drug cessation.
- Severe non-cardiovascular comorbidity with life expectancy \< 3 months.
- Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders.
- Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation.
- Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization.
- Participants who have large areas (greater than half of middle cerebral artery territory) of obvious low density on the baseline CT scan.
- Gastrointestinal bleed within 3 months or major surgery within 30 days.
- Diagnosis or suspicious diagnosis of acute coronary syndrome.
- Participation in another clinical study with an experimental product during the last 30 days.
- Currently receiving an experimental drug or device.
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- Dezhou, Shandong, China
- Liaocheng, Shandong, China
- Yantai, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China; Dezhou, Shandong, China; Liaocheng, Shandong, China; Yantai, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.