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
- Are there results?
- Not yet: the study is under way
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:
Show all 32Show fewer
- 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.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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）
- ClinicalTrials.gov ID
- NCT06319846
- Acronym / sponsor ID
- ZLRK202312
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,674 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban group | Experimental | Drug: TirofibanInitial 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 | Placebo comparator | Drug: PlaceboInitial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40 years or older than 40 years;
- Acute cerebral ischemic event due to:
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirofibanInitial 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. | Drug | Tirofiban group |
| PlaceboInitial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours. | Drug | Placebo group |
Primary outcome
Any new ischemic stroke at 3-month
Time frame: at 3-month
Incidence of any new ischemic stroke at 3-month
Type 3 or 5 bleeding events according to the BARC criteria at 3-month
Time frame: at 3-month
Incidence of type 3 or 5 bleeding events according to the BARC criteria at 3-month
5 secondary outcomes
Any new ischemic stroke within 1 year
Time frame: 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.
Time frame: Within 3 months after randomization and 1 year
Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year
Time frame: at 3 months and 1 year
Incidence and severity of recurrent stroke and TIA
Time frame: Within 3 months after randomization and 1 year
Neurological impairment at 3 months (NIHSS increased≥4 from baseline ).
Time frame: at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirofiban in people with Ischemic Stroke, Acute and TIA, run by Beijing Tiantan Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang (13911172565, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any new ischemic stroke at 3-month (time frame: at 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.