Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

40 years or older than 40 years;

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.);

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tirofiban
  • Placebo

Treatment groups

4,674 Participants
are divided into 2 treatment groups

Sponsors and collaborators