NCT05445895已完成4 期
A Prospective, Randomized, Active-controlled, Double-blind, Parallel, Multi-center, Phase IV, Exploratory Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 1
- 主要终点
- - The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
研究概览
简要总结
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
排除标准
- •Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
- •With a modified Rankin Score (mRS) of 3 or higher before onset.
- •Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
- •History of hypersensitivity to IP or components
- •Not suitable for aspirin administration at the discretion of the investigator
研究组 & 干预措施
Renexin CR 200/160mg
Experimental
Renexin CR 200/160mg will be added to Aspirin 100mg
干预措施: Renexin CR 200/160mg (Drug)
Clopidogrel 75mg
Active Comparator
Plavix 75mg will be added to Aspirin 100mg
干预措施: Plavix 75mg (Drug)
结局指标
主要结局
- The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
时间窗: up to 90 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)Amyloidosis, HereditaryAmyloid Neuropathies, FamilialAmyloid NeuropathiesAmyloidosis, Hereditary, Transthyretin-RelatedFamilial Transthyretin Cardiac AmyloidosisNCT02319005Alnylam Pharmaceuticals206
进行中（未招募）
1 期
A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)Secondary Central Nervous System LymphomaPrimary Central Nervous System LymphomaNCT05485753Sichuan Baili Pharmaceutical Co., Ltd.7
进行中（未招募）
不适用
Study to investiagte the effect of Neurexan vs natural course in healthy volunteers under an experimental acute stress settingeurexan to be effective in fostering mental balance by reducing tension and nervousness during acute stress setting in healthy probandsMedDRA version: 15.1Level: LLTClassification code 10042219Term: Stress testSystem Organ Class: 100000004848EUCTR2012-002359-40-DEBiologische Heilmittel Heel GmbH
已完成
1 期
Effects of Aliskiren, Irbesartan, and the Combination in Hypertensive Patients With Type 2 Diabetes and Diabetic NephropathyDiabetes Type 2NCT00464880Novartis24
已完成
2 期
Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney DiseaseDiabetic Kidney DiseaseNCT05593575Shanghai Pharmaceuticals Holding Co., Ltd305