The Effects of Cilostazol Dexborneol on Microcirculation Dysfunction and Thrombo-inflammation in Patients With Acute Ischemic Stroke After Reperfusion Therapy

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: NeuroDawn Pharmaceutical Co., Ltd.

Criteria

Inclusion criteria:

• 35 years old ≤ Age ≤ 80 years old

• Patients with acute ischemic stroke was diagnosed within 24 hours of onset (time from onset to completion of reperfusion therapy)

• Patients with first stroke or prior to stroke onset (mRS score 0-1)

• Patients with acute large vessel occlusion (LVO) confirmed by imaging, including the responsible vessel was located in the intracranial internal carotid artery, the T-shaped branch, the M1/M2 segment of the middle cerebral artery, or the A1/A2 segment of the anterior cerebral artery

• ASPECTS score ≥ 6

• 6- Patients who meet the indications for reperfusion therapy, including mechanical thrombectomy, bridging therapy (intravenous r-tPA thrombolytic therapy), and plan to undergo mechanical thrombectomy

• Patients or his/her legal representatives are able to understand and sign the informed consent

Exclusion criteria:

• Severe consciousness disturbance: NIHSS 1a consciousness level ≥2 points

• Patients with definite history of intracranial hemorrhage (such as subarachnoid hemorrhage, cerebral hemorrhage, etc.)

• Patients with intracranial tumor, arteriovenous malformation, or aneurysm

• Patients with bilateral anterior or posterior circulation ischemic stroke

• Patients with large vascular occlusion of rare or unknown etiology, such as dissection, vasculitis, etc.

• Patients who have received treatment with dual antiplatelet drugs, tirofiban, warfarin, novel oral anticoagulant, argatroban, snake venom, defibrase, lumbrokinase and other defibrase therapy after the onset of disease

• Patients with severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons before randomization (severe hepatic insufficiency is defined as ALT > 3 × ULN or AST >3 × ULN; severe renal insufficiency is defined as serum creatinine >3.0 mg/dL (265.2 μmol/L) or creatinine clearance < 30 mL/min)

• Patients with haemorrhagic diathesis (including but not limited to): platelet count < 100 × 109/L; heparin treatment within the last 48 hours; taking oral warfarin; taking novel oral anticoagulant; administration with direct thrombin or Xa factor inhibitors; with hereditary hemorrhagic disorders, such as hemophilia

• 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 significant head trauma or stroke within 3 months 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 hemorrhagic retinopathy

• Male subjects (or their partners) 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 agent or other contrast agents; subjects 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 advanced disease, leading to life expectancy of < 6 months

• Patients who have received treatment of investigational drug or device within 3 months

• Other conditions where it is not suitable for patients to participate in the clinical trial, such as inability to understand and/or follow the study procedures and/or follow-up schedule due to psychiatric disorders or cognitive/emotional disorders, or contraindications to thrombectomy or MRI, etc.