Cilostazol Dexborneol for improving blood flow after stroke

Cilostazol Dexborneol Versus Placebo for Microcirculation Dysfunction After Reperfusion Therapy in Patients With Acute Ischemic Stroke With Large Vessel Occlusion: A Phase Ⅱa,Prospective,Multicenter,Randomized, Double-blind,Placebo-controlled Parallel Trial

This study is testing if a new tablet can help improve blood flow and recovery in people who have had a stroke caused by a blocked blood vessel.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 3 sites (Liuzhou, Guangxi and 2 other locations)
• Trial ID: NCT05836766 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Y-6 sublingual tablets in enhancing microcirculation and reducing inflammation in patients who have experienced an acute ischemic stroke due to large vessel occlusion and have undergone reperfusion therapy. The study aims to determine the safety and efficacy of this multi-component treatment by measuring recovery on the modified-Rankin scale at 90 days post-treatment. Participants will be monitored through a series of follow-up visits over three months to assess their progress and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35 to 80 who have experienced their first acute ischemic stroke due to large vessel occlusion and are eligible for reperfusion therapy.

Not a fit: Patients with severe consciousness disturbances or those who do not meet the inclusion criteria for reperfusion therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for stroke patients by enhancing blood flow and reducing inflammation.

How similar studies have performed: While the approach of using cilostazol and dexborneol in this context is innovative, similar studies have shown promise in improving outcomes for stroke patients, suggesting potential for success.

Eligibility 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\<NIHSS score ≤ 25 after the onset of this disease
* 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.

Where this trial is running

Liuzhou, Guangxi and 2 other locations

• Liuzhou Workers' Hospital — Liuzhou, Guangxi, China (RECRUITING)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (RECRUITING)
• Pingxiang people's hospital — Pingxiang, Jiangxi, China (RECRUITING)

Study contacts

• Principal investigator: Yilong Wang, PhD，MD — Beijing Tiantan Hospital, Capital Medical University, Beijing, China
• Study coordinator: Yilong Wang, PhD，MD

Conditions: Acute Ischemic Stroke, Reperfusion, Large Vessel Occlusion, microcirculation dysfunction, Y-6, cilostazol, dexborneol, Thrombo-inflammation