Clinical trial NCT00724724: The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
Official title: The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Transient Ischemic Attack
Keywords: Stroke
Transient Ischemic Attack
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP) in Secondary Prevention of Ischemic Stroke

Detailed description: The efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP)in acute ischemic stroke has been demonstrated in China recently. Its role in secondary prevention of ischemic stroke need to be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Ischemic cerebral infarction or TIA within 90 days.
2. Aged above 40 years old.
3. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
4. Stable clinical and neurological conditions.
5. Informed consent is obtained.

Exclusion Criteria:

1. Intracranial hemorrhage
2. Stroke of other unkonwn causes, or other known causes, such as Takayasu arteritis, Moyamoya disease, dissecting aneurysm and hypercoagulable state, carotid endarterectomy, angiogram, or cardiac surgery
3. Cardio embolism
4. Patients with anticoagulants treament including heparin or warfarin
5. Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
6. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
7. A Modified Rankin score is more than 4
8. Abnormal liver function: ALT or AST level \>1.5 times upper limit of normal; Abnormal renal function: serum creatinine level \>2.0mg/dl or 177umol/l:
9. Concurrent participation in another clinical trial
10. Uncontrolled hypertension : systolic blood pressure greater than 180mmHg, or diastolic blood pressure greater than 100mmHg
11. Haemostatic disorder or thrombocytopenia (i.e., PLT\<100×109/l).
12. Currently active peptic ulcer disease
13. Pregnant or breast feeding
14. Planned for major surgery, carotid endarterectomy, or carotid angioplasty
15. Unable to give informed consent.

Primary outcomes:
measure: Newly onset ischemic stroke
timeFrame: 1 year follow up
measure: vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
timeFrame: 1 year follow up
measure: Small vessel disease defined by white matter lesions on MRI
timeFrame: 1 year follow up
Secondary outcomes:
measure: All-cause death
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hosptial
state: Beijing
city: Beijing
country: China
facility: China Pla General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: China Rehabilition Research Center
state: Beijing
city: Beijing
country: China
facility: General Hospital of Navy
state: Beijing
city: Beijing
country: China
facility: Luhe Hospital of Tongzhou Distict Beijing
state: Beijing
city: Beijing
country: China
facility: No 263 Hospital of Pla
state: Beijing
city: Beijing
country: China
facility: No 309 Hospital of Pla
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Pinggu County Hospital Beijing
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou First Municipal People'S Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-Sen Unversity
state: Guangdong
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Yutian
country: China
facility: Yutian County Hospital
state: Hebei
city: Zhangjiakou
country: China
facility: Hebei North University
state: Hebei
city: Harbin
country: China
facility: The First Hospital of Harbin Medical University
state: Helongjiang
city: Harbin
country: China
facility: The Second Hospital of Harbin Medical University
state: Helongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People'S Hospital
state: Henan
city: Wuhan
country: China
facility: The Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
state: Hunan
city: Baotou
country: China
facility: Inner Mongolia Baotou City Central Hospital
state: Inner Mongolia
city: Chifeng
country: China
facility: The Appurtenant Hospital of Chifeng University
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command
state: Jiangsu
city: Nanjing
country: China
facility: The Affiliated Drumtower Hospital of Nanjing University Medical School
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: Jilin University
state: Jilin
city: Dalian
country: China
facility: The Third People'S Hospital of Dalian
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical Sciences University
state: Liaoning
city: Xining
country: China
facility: Qinghai Provincial People'S Hospital
state: Qinghai
city: Jinan
country: China
facility: Qilu Hospital of Shangdong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospitalof Shangdong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Center of Medical Sciences
state: Sichuan
city: Tianjin
country: China
facility: The General Hospital Under Tianjin Medical Sciences University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Uramuqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang uygur autonomous region
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: