The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial

Stroke Clinical Trial

— ESCAPE  

Official title:

The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00724724
• Other study ID #: 2006BAI01A10-3
• Status: Recruiting
• Phase: Phase 4
• First received: July 26, 2008
• Last updated: February 23, 2011
• Start date: August 2008
• Est. completion date: August 2011

Study information

• Verified date: February 2011
• Source: Peking Union Medical College Hospital
• Contact: Liying Cui
• Phone: 86-10-65296373
• Email: pumchcly[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• Butylphthalide Soft Capsules
Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
• Aspirin
Aspirin 100mg Qd for 1 year

Locations

Country	Name	City	State
China	Inner Mongolia Baotou City Central Hospital	Baotou	Inner Mongolia
China	Beijing Daxing District Hospital	Beijing	Beijing
China	Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University	Beijing	Beijing
China	Beijing Shijitan Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing
China	China Pla General Hospital	Beijing	Beijing
China	China Rehabilition Research Center	Beijing	Beijing
China	General Hospital of Navy	Beijing	Beijing
China	Luhe Hospital of Tongzhou Distict Beijing	Beijing	Beijing
China	No 263 Hospital of Pla	Beijing	Beijing
China	No 309 Hospital of Pla	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking Union Medical College Hosptial	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Pinggu County Hospital Beijing	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Jilin University	Changchun	Jilin
China	Xiangya Hospital of Centre-South University	Changsha	Hunan
China	West China Center of Medical Sciences	Chengdu	Sichuan
China	The Appurtenant Hospital of Chifeng University	Chifeng	Inner Mongolia
China	Daping Hospital	Chongqing	Chongqing
China	Southwest Hospital	Chongqing	Chongqing
China	The Third People'S Hospital of Dalian	Dalian	Liaoning
China	Guangzhou First Municipal People'S Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital,Sun Yat-Sen Unversity	Guangzhou	Guangdong
China	Second Affiliated Hospital Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Hospital of Harbin Medical University	Harbin	Helongjiang
China	The Second Hospital of Harbin Medical University	Harbin	Helongjiang
China	Qilu Hospital of Shangdong University	Jinan	Shandong
China	The Second Hospitalof Shangdong University	Jinan	Shandong
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu
China	The Affiliated Drumtower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical Sciences University	Shenyang	Liaoning
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The General Hospital Under Tianjin Medical Sciences University	Tianjin	Tianjin
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xinjiang Medical University	Uramuqi	Xinjiang uygur autonomous region
China	The Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Qinghai Provincial People'S Hospital	Xining	Qinghai
China	Yutian County Hospital	Yutian	Hebei
China	Hebei North University	Zhangjiakou	Hebei
China	Henan Provincial People'S Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newly onset ischemic stroke		1 year follow up	Yes
Primary	vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery		1 year follow up	Yes
Primary	Small vessel disease defined by white matter lesions on MRI		1 year follow up	Yes
Secondary	All-cause death		1 year follow up	Yes