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

NCT06319846 | Recruiting Phase 3 DMC

• 1 other identifier: ZLRK202312
• Study Type: interventional
• Target: 4,674
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Ischemic Stroke, Acute; TIA; Symptomatic Intracranial Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• Any new ischemic stroke at 3-month

  Incidence of any new ischemic stroke at 3-month

  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

  at 3-month

Secondary Outcomes (5)

• Any new ischemic stroke within 1 year

  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.

  Within 3 months after randomization and 1 year

• Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year

  at 3 months and 1 year

• Incidence and severity of recurrent stroke and TIA

  Within 3 months after randomization and 1 year

• Neurological impairment at 3 months (NIHSS increased≥4 from baseline ).

  at 3 months

Other Outcomes (5)

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

  at 1 year

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

  at 3-month and 1-year

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

  at 3-month and 1-year

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Tirofiban group

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.

Placebo group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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%.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (5)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

RECRUITING

People's Hospital of Qihe County

Dezhou, Shandong, 251199, China

RECRUITING

Liaocheng People's Hospital（Liaocheng Brain Hospital）

Liaocheng, Shandong, 252001, China

RECRUITING

Third People's Hospital of Liaocheng

Liaocheng, Shandong, 252004, China

RECRUITING

Yantai Penglai traditional Chinese medicine hospital

Yantai, Shandong, 265699, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yongjun Wang

CONTACT

13911172565; yongjunwang@ncrcnd.org.cn

Jing Jing

CONTACT

15810312511; jingj_bjttyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: July 11, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)