EFfects of Y-6 SUblingual Tablets foR PaTients With AcUte Ischemic StRokE (FUTURE)

NCT06138834 | Unknown Phase 2 DMC

• 1 other identifier: YW2023-038-02
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy of Y-6 sublingual tablets in improving microcirculation dysfunction and reducing thrombo-inflammation in patients who had AIS caused by LVO and received reperfusion therapy. Moreover, we expect to evaluate the safety of using Y-6 sublingual tablet in such study population.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Reperfusion

Keywords

Y-6; cilostazol; dexborneol; acute ischemic stroke; large vessel occlusion; reperfusion therapy; FUTURE

Outcome Measures

Primary Outcomes (1)

• Proportion of mRS score recovered to 0~1 score

  The modified Rankin Scale (mRS) decreasing to 0\~1 score. mRS Mainly measures patients' independent living ability, including physical function, activity ability and participation in daily life. A score of 0 on the mRS Scale indicates no symptoms and a score of 5 indicates severe disability.

  At 90±7 days after randomization

Secondary Outcomes (4)

• The mRS score at 90±7 days after randomization

  At 90±7 days after randomization

• Changes of NIHSS score between baseline and at 24 ± 2 hours, 7 ± 2 days and 28 + 3 days after randomization

  At 24 ± 2 hours, 7 ± 2 days and 28 + 3 days after randomization

• Proportion of patients with early progression of stroke at 24 ± 2 hours after randomization

  At 24 ± 2 hours after randomization

• Proportion of patients with combined vascular events at 90 ± 7 days after randomization

  At 90 ± 7 days after randomization

Study Arms (5)

Low-dose Y-6 sublingual tablet group

EXPERIMENTAL

One Y-6 sublingual tablet (each tablet contains 25 mg Cilostazol and 6 mg Dexborneol), one placebo of Y-6 sublingual tablet (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), and two halves Cilostazol mimicry tablets (each tablet contains 0 mg Cilostazol).

Drug: Low-dose Y-6 sublingual tablets

High-dose Y-6 sublingual tablet group

EXPERIMENTAL

Two Y-6 sublingual tablets (each tablet contains 25 mg Cilostazol and 6 mg Dexborneol), and two halves Cilostazol mimicry tablets (each tablet contains 0 mg Cilostazol).

Drug: High-dose Y-6 sublingual tablets

Low-dose Cilostazol group

EXPERIMENTAL

Two tablets of placebo of Y-6 sublingual tablets (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), one half Cilostazol tablet (each tablet contains 50 mg Cilostazol), and one half Cilostazol mimicry tablet(each tablet contains 0 mg Cilostazol).

Drug: Low-dose Cilostazol

High-dose Cilostazol group

EXPERIMENTAL

Two tablets of placebo of Y-6 sublingual tablets (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), and two halves Cilostazol tablet (each tablet contains 50 mg Cilostazol).

Drug: High-dose Cilostazol

Placebo group

PLACEBO COMPARATOR

Two tablets of placebo of Y-6 sublingual tablets (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), and two halves Cilostazol mimicry tablets (each tablet contains 0 mg Cilostazol).

Drug: Placebo

Interventions

Low-dose Y-6 sublingual tablets DRUG

Take one Y-6 sublingual tablet (each tablet contains 25 mg Cilostazol and 6 mg Dexborneol), one placebo of Y-6 sublingual tablet (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), and two halves Cilostazol mimicry tablets (each tablet contains 0 mg Cilostazol) for 28 days continuously.

Low-dose Y-6 sublingual tablet group

High-dose Y-6 sublingual tablets DRUG

Take two Y-6 sublingual tablets (each tablet contains 25 mg Cilostazol and 6 mg Dexborneol), and two halves Cilostazol mimicry tablets (each tablet contains 0 mg Cilostazol) for 28 days continuously.

High-dose Y-6 sublingual tablet group

Low-dose Cilostazol DRUG

Take two tablets of placebo of Y-6 sublingual tablets (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), one half Cilostazol tablet (each tablet contains 50 mg Cilostazol), and one half Cilostazol mimicry tablet(each tablet contains 0 mg Cilostazol) for 28 days continuously.

Low-dose Cilostazol group

High-dose Cilostazol DRUG

Take two tablets of placebo of Y-6 sublingual tablets (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), and two halves Cilostazol tablet (each tablet contains 50 mg Cilostazol) for 28 days continuously.

High-dose Cilostazol group

Placebo DRUG

Take two tablets of placebo of Y-6 sublingual tablets (each tablet contains 0 mg Cilostazol and 0.06 mg Dexborneol to simulate the cool taste of Y-6 sublingual tablets when taken), and two halves Cilostazol mimicry tablets (each tablet contains 0 mg Cilostazol) for 28 days continuously.

Placebo group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ Age ≤ 80 years old;
• Patients with acute ischemic stroke diagnosed within 24 hours of onset (time from onset to start of endovascular treatment);
• Patients with first stroke or mRS score 0-1 prior to this onset ;
• Patients with acute intracranial large vessel occlusion (LVO) confirmed by imaging examination, including occlusion of intracranial segments of internal carotid arteries, T-shaped bifurcation, MCA M1 and/or M2 segments and ACA A1 and/or A2 segments;
• ASPECTS score ≥ 6 when screening;
• \<NIHSS score ≤ 25 after this onset;
• Patients who had the indications for mechanical thrombectomy and were scheduled for endovascular treatment;
• Patients or his/her legal representatives were able to understand and sign the informed consent.

You may not qualify if:

• Severe disorder of consciousness: NIHSS 1a consciousness level ≥2 points;
• Patients with definite history of intracranial hemorrhage, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc. when screening;
• Patients with previously diagnosed intracranial tumor, arteriovenous malformation, or aneurysm when screening;
• Patients with bilateral LVO at anterior circulation or LVO at posterior circulation when screening;
• Patients with LVO of unknown or rare etiology, e.g., due to dissection, vasculitis, etc. when screening;
• Patients who have received treatment with tirofiban, warfarin, novel oral anticoagulants, argatroban, snake venom, defibrase, lumbrokinase or other defibrase therapy after onset, or platelet count \<100×10\^9/L;
• Patients with severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons when screening (severe hepatic insufficiency was defined as ALT \> 3 × ULN or AST \>3 × ULN; severe renal insufficiency was defined as serum creatinine \>3.0 mg/dl (265.2 μmol/L) or creatinine clearance \< 30 ml/min);
• Patients with previously diagnosed hemorrhagic tendency (including but not limited to): with hereditary hemorrhagic disorders, such as hemophilia, when screening;
• Patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg);
• Patients with history of major head trauma or stroke within 1 month prior to randomization;
• Patients who have received intracranial or spinal surgery within 3 months prior to randomization;
• Patients with history of major surgery or serious physical trauma within 1 month prior to randomization;
• Patients with previously diagnosed hemorrhagic retinopathy;
• Male subjects (or their mates) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period;
• Patients with contraindications to known contrast agents or other contrast agents; patients who are allergic to Cilostazol or Dexborneol;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Neurodawn Pharmaceutical Co., Ltd.: collaborator

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MeSH Terms

Conditions

Ischemic Stroke

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yilong Wang, PhD+MD

  Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilong Wang, PhD+MD

CONTACT

0086-010-67092222; yilong528@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share