2024-07-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-07→confirmed 2024-07-11
Study sitesdetails revised at 5 of 5 sites
2024-07-05
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Primary completion date2025-06→2025-10
Completion date2026-06→2026-12
Start date2024-03→2024-07
InterventionsTirofiban (Drug), Tirofiban placebo (Drug)→Placebo (Drug), Tirofiban (Drug)
Eligibility criteria+368 characters
Inclusion Criteria:
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1.40 years or older than 40 years.;
2.Acute cerebral ischemic event due to： :
Acute mildnon-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.SymptomaticAccompanied intracranialwith artery stenosis (symptomatic intracranial artery stenosis is, defined as ≥ 50% stenosis of the supplyinginfarcted ipsilateral intracranial artery.
Intracranial arteries include intracranial segments of internal carotid arteries, intracranial segments of vertebral arteries, M1-M2 segme [...] [...]
Secondary endpoints5 entries, revised
NewAny new ischemic stroke within 1 year
AnyNew clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular eventsevent will be independently evaluated.
Proportion of patients with disablingDisabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year
OccurrenceIncidence and severity of recurrent stroke orand transient ischemic attackTIA
Proportion of patients with aggravated neurologicalNeurological impairment at 3 months (NIHSS increased≥4 from baseline ).
Primary endpoints2 entries, revised
BARCAny typenew ischemic stroke at 3-month
Type 3 or type 5 bleeding
New ischemicevents strokeaccording to the BARC criteria at 3-month
Study description-1,190 characters
The CHANCE-4 studyThis is a multicenter, double-blind, double-simulationdummy, randomized controlledclinical study.
Intrial to assess the effects of tirofiban versus placebo in preventing recurrence of stroke at 3-month in patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic 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 [...] [...]