EFfects of Y-6 SUblingual Tablets foR PaTients With AcUte Ischemic StRokE (FUTURE)
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full description
This study rationale is based on the following scheme: in patients with acute ischemic stroke caused by LVO, receiving reperfusion therapy may cause futile recanalization and thus lead to microcirculation dysfunction and thrombo-inflammation as consequences. Cilostazol has antiplatelet effects and BBB protection and Dexborneol has anti-inflammatory effects; therefore, the multi-component tablet may exert neuroprotective effects in terms of improving microcirculation dysfunction and reducing thrombo-inflammation in patients with AIS after reperfusion therapy.
The primary purpose of this study is to investigate the proportion of modified-Rankin scale (mRS) score recovered to 0~1 score at 90±7 days after randomization.
The follow-up duration is 3 months, and the visit schedule is as follows: Subjects enrolled based on randomization procedures will receive visits at screening/baseline period, 24 ± 2 hours, 7 ± 2 days, 28 + 3 days and 90 ± 7 days after randomization, and in case of any events.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 35 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;
- 6<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.
Exclusion criteria
- 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;
- Patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs;
- Patients with life expectancy of less than 3 months due to advanced stage of comorbidity;
- Patients who have received treatment of investigational drugs or devices within previous 3 months;
- Other investigator-evaluated conditions which may influence the compliance of patients or where it is not suitable for patients to participate in this trial.
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 5 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Yilong Wang, PhD+MD
Data sourced from clinicaltrials.gov
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