Acute Ischemic Stroke Clinical Trial
Official title:
Effects of Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke: A Phase Ⅱ, Randomized, Double-blind, Double-dummy, Placebo-controlled Parallel Trial
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | January 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Beijing Tiantan Hospital | NeuroDawn Pharmaceutical Co., Ltd. |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The mRS score at 90±7 days after randomization | 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 | Changes of NIHSS score between baseline and at 24 ± 2 hours, 7 ± 2 days and 28 + 3 days after randomization | NIHSS score after reperfusion therapy within 2 hours changing compared with baseline NIHSS. The NIHSS score ranges from 0 to 42. The higher the score, the more severe the nerve damage. | At 24 ± 2 hours, 7 ± 2 days and 28 + 3 days after randomization | |
Secondary | Proportion of patients with early progression of stroke at 24 ± 2 hours after randomization | Early progression of stroke was defined as: within 7 days after onset, compared to baseline, an increase of = 2 points in NIHSS; or an increase of = 1 point in limb hemiplegia; or an increase of = 1 point in consciousness disorder, excluding those caused by intracranial hemorrhage and other non-stroke causes such as cardiac insufficiency, liver insufficiency, renal insufficiency, etc. | At 24 ± 2 hours after randomization | |
Secondary | Proportion of patients with combined vascular events at 90 ± 7 days after randomization | Combined vascular events were defined as: symptomatic stroke, myocardial infarction and vascular death. | At 90 ± 7 days after randomization |
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