CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 300 target
Drug / intervention
Low-dose Y-6 sublingual tablets +4 moredrug
Likely dose
Low-dose Y-6 sublingual tablets 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06138834
NCT06138834Phase 2Unknown

Effects of Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke: A Phase Ⅱ, Randomized, Double-blind, Double-dummy, Placebo-controlled Parallel Trial

Beijing Tiantan Hospital·interventional·Posted Nov 18, 2023·Updated Nov 18, 2023

In Brief

A Phase 2 clinical trial evaluating Low-dose Y-6 sublingual tablets, High-dose Y-6 sublingual tablets, and 3 other interventions for Acute Ischemic Stroke and 2 related conditions. Targeting 300 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 2UnknownOverdue
202420252026
First PostedNov 18, 2023
Enrollment StartNov 1, 2023
Primary CompletionNov 1, 2024
Study CompletionJan 1, 2025
TodayJul 1, 2026
Enrollment to primary: 1 yearPosted 2.6 years ago

Interventions

Low-dose Y-6 sublingual tabletsdrug

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.

High-dose Y-6 sublingual tabletsdrug

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.

Low-dose Cilostazoldrug

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.

High-dose Cilostazoldrug

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.

Placebodrug

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.