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

ConditionsIschemic Stroke, Acute TIA Symptomatic Intracranial Artery Stenosis

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Tirofiban
Drug
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
Drug
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.

Treatment groups

4,674 Participants

are divided into 2 treatment groups

Group A: Tirofiban groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Any new ischemic stroke at 3-month

Incidence of any new ischemic stroke at 3-month

Time frame

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

Time frame

at 3-month

Secondary outcomes

Any new ischemic stroke within 1 year

Incidence of 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.

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.

Time frame

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).

Time frame

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)

Time frame

Within 3 months after randomization and 1 year

Other outcomes

Type 3 or 5 bleeding events (BARC definition) at 1 year

Proportion of patients with type 3 or 5 bleeding events (BARC definition) at 1 year.

Time frame

at 1 year

Type 2, 3 or 5 bleeding events according to the BARC criteria at 3-month and 1-year.

Proportion of patients with type 2, 3 or 5 bleeding events according to the BARC criteria at 3-month and 1-year.

Time frame

at 3-month and 1-year

All bleeding events (type 1-5 bleeding events according to the BARC criteria)

All bleeding events (type 1-5 bleeding events according to the BARC criteria) at 3-month and 1-year; Each bleeding event will be independently evaluated

Time frame

at 3-month and 1-year

Total mortality at 3-month and 1-year

Proportion of patients with total mortality at 3-month and 1-year

Time frame

at 3-month and 1-year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

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