Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
NCT ID: NCT06319846
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4674 participants
INTERVENTIONAL
2024-07-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Tirofiban group
Initial infusion of tirofiban 0.4μg/kg body weight/minute for 30 minutes (a maximum dose of 1mg) within 24 hours of symptom onset, followed by a continuous infusion of tirofiban 0.1μg/kg body weight/minute for 48 hours.
Tirofiban
Initial infusion of tirofiban 0.4μg/kg body weight/minute for 30 minutes (a maximum dose of 1mg) within 24 hours of symptom onset, followed by a continuous infusion of tirofiban 0.1μg/kg body weight/minute for 48 hours.
Placebo group
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
Placebo
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
Interventions
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Tirofiban
Initial infusion of tirofiban 0.4μg/kg body weight/minute for 30 minutes (a maximum dose of 1mg) within 24 hours of symptom onset, followed by a continuous infusion of tirofiban 0.1μg/kg body weight/minute for 48 hours.
Placebo
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
Eligibility Criteria
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Inclusion Criteria
2. 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);
3. 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, intracranial segments of vertebral arteries, M1-M2 segments of middle cerebral arteries, A1-A2 segments of anterior cerebral arteries, P1-P2 segments of posterior cerebral arteries, and basilar artery. The techniques for detecting intracranial artery stenosis are limited to: MRA, CTA, or DSA. The measurement for the degree of stenosis has been established by the WASID (Warfarin-Aspirin Symptomatic Intracranial Disease) study. (AJNR Am J Neuroradiol. 2000;21:643-646.);
4. Can be treated with study drug within 24 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
5. Informed consent signed.
Exclusion Criteria
2. Unable to complete the evaluation of intracranial artery stenosis before randomization.
3. 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.
4. Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA.
5. A score of \> 2 on the modified Rankin scale before the symptom onset.
6. 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)
7. Tirofiban has been used since this onset.
8. Hematocrit (HCT) \<30%.
9. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
10. History of intracranial hemorrhage or amyloid angiopathy.
11. History of aneurysm (including intracranial aneurysm and peripheral aneurysm).
12. History of asthma or COPD (chronic obstructive pulmonary disease).
13. High-risk for bradyarrhythmia (sinus node disease, first-degree or second-degree AV block, and brady-arrhythmic syncope without pacemaker).
14. Planned or likely revascularization (any angioplasty or endovascular surgery) within the next 3 months.
15. Scheduled for surgery or interventional treatment requiring study drug cessation.
16. Severe non-cardiovascular comorbidity with life expectancy \< 3 months.
17. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders.
18. Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation.
19. Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization.
20. Participants who have large areas (greater than half of middle cerebral artery territory) of obvious low density on the baseline CT scan.
21. Gastrointestinal bleed within 3 months or major surgery within 30 days.
22. Diagnosis or suspicious diagnosis of acute coronary syndrome.
23. Participation in another clinical study with an experimental product during the last 30 days.
24. Currently receiving an experimental drug or device.
25. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control.
40 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Yongjun Wang
President of Beijing Tiantan Hospital
Locations
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The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
People's Hospital of Qihe County
Dezhou, Shandong, China
Liaocheng People's Hospital（Liaocheng Brain Hospital）
Liaocheng, Shandong, China
Third People's Hospital of Liaocheng
Liaocheng, Shandong, China
Yantai Penglai traditional Chinese medicine hospital
Yantai, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZLRK202312
Identifier Type: -
Identifier Source: org_study_id
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