Ischemic Stroke, AcutePhase 3NCT06319846
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
A Phase 3 study testing Tirofiban in people with Ischemic Stroke, Acute and TIA, run by Beijing Tiantan Hospital at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, TIA, Symptomatic Intracranial Artery Stenosis
- What is being tested?
- Tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,674 participants
- Where
- 5 sitesChina
- Study dates
- 11 Jul 2024to Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, 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.);
- 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.
Who cannot join
- 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:
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- 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 interventional 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
People's Hospital of Qihe County
Dezhou, Shandong, 251199
Haitao Li, 13869215737, userfiled@126.com
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Lihua Wang, 13100881600, wanglh211@163.com
- Recruiting
Liaocheng People's Hospital（Liaocheng Brain Hospital）
Liaocheng, Shandong, 252001
Xiafeng Yang, 13326356005, Cranialnerves@163.com
- Recruiting
Third People's Hospital of Liaocheng
Liaocheng, Shandong, 252004
Liguo Chang, 17763559299, chliguo@163.com
- Recruiting
Yantai Penglai traditional Chinese medicine hospital
Yantai, Shandong, 265699
Penglai Shi, 18953551266, 452405222@qq.com
About this study
Official title: 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(CHANCE-4）
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.
Read the detailed description
This is a multicenter, double-blind, double-dummy, randomized clinical trial to assess the effects of tirofiban versus placebo in preventing recurrence of stroke at 3-month in patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events. The participants will receive study medication of tirofiban or placebo within 24 hours of symptom onset by a randomization ratio of 1:1. For 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. For 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. The primary efficacy outcome is any new ischemic stroke at 3-month. The primary safety outcome is type 3 or 5 bleeding events according to the BARC criteria at 3-month.
- Being tested
- Tirofiban, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
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.
PlaceboDrug
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban group | Experimental | 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. Receives: Drug: Tirofiban |
| Placebo group | Placebo comparator | Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any new ischemic stroke at 3-month
Incidence of any new ischemic stroke at 3-month
Measured: at 3-month
Type 3 or 5 bleeding events according to the BARC criteria at 3-month
Incidence of type 3 or 5 bleeding events according to the BARC criteria at 3-month
Measured: at 3-month
Secondary outcomes (5)
Any new ischemic stroke within 1 year
Incidence of any new ischemic stroke within 1 year
Measured: within 1 year
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.
Incidence of new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.
Measured: Within 3 months after randomization and 1 year
Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year
Proportion of patients with disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Measured: at 3 months and 1 year
Incidence and severity of recurrent stroke and TIA
Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year (Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke/severe non-fatal stroke [mRS 4 or 5]/moderate stroke [mRS 2 or 3]/mild stroke [mRS 0 or 1]/TIA/no stroke-TIA)
Measured: Within 3 months after randomization and 1 year
Neurological impairment at 3 months (NIHSS increased≥4 from baseline ).
Proportion of patients with neurological impairment at 3 months ( National Institutes of Health Stroke Scale [NIHSS] score increased≥4 from baseline).
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start11 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,674 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319846
- Sponsor's protocol ID
- ZLRK202312
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No