search
Back to results

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

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Butylphthalide Soft Capsules
Aspirin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Transient Ischemic Attack

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital
  • Peking Union Medical College Hospital
  • Peking Union Medical College Hosptial
  • China Pla General Hospital
  • Beijing Daxing District Hospital
  • Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
  • Beijing Shijitan HospitalRecruiting
  • Beijing Tiantan Hospital
  • China Rehabilition Research Center
  • General Hospital of Navy
  • Luhe Hospital of Tongzhou Distict Beijing
  • No 263 Hospital of Pla
  • No 309 Hospital of Pla
  • Peking University Third Hospital
  • Pinggu County Hospital Beijing
  • Xuanwu Hospital Capital Medical University
  • Daping Hospital
  • Southwest Hospital
  • Guangzhou First Municipal People'S Hospital
  • The First Affiliated Hospital,Sun Yat-Sen Unversity
  • The First Hospital of Hebei Medical University
  • The Second Hospital of Hebei Medical University
  • The Third Hospital of Hebei Medical University
  • Yutian County Hospital
  • Hebei North University
  • The First Hospital of Harbin Medical University
  • The Second Hospital of Harbin Medical University
  • Henan Provincial People'S Hospital
  • The Zhongnan Hospital of Wuhan University
  • Xiangya Hospital of Centre-South University
  • Inner Mongolia Baotou City Central Hospital
  • The Appurtenant Hospital of Chifeng University
  • Jiangsu Province Hospital
  • Nanjing General Hospital of Nanjing Military Command
  • The Affiliated Drumtower Hospital of Nanjing University Medical School
  • The Second Affiliated Hospital of Soochow University
  • Jilin University
  • The Third People'S Hospital of DalianRecruiting
  • The First Affiliated Hospital of China Medical Sciences University
  • Qinghai Provincial People'S Hospital
  • Qilu Hospital of Shangdong University
  • The Second Hospitalof Shangdong University
  • Huashan Hospital Fudan University
  • Shanghai Changzheng Hospital
  • West China Center of Medical Sciences
  • The General Hospital Under Tianjin Medical Sciences UniversityRecruiting
  • Tianjin Third Central Hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • Second Affiliated Hospital Zhejiang University College of Medicine
  • The First Affiliated Hospital of College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Butylphthalide Soft Capsules + Aspirin

Aspirin

Outcomes

Primary Outcome Measures

Newly onset ischemic stroke
vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
Small vessel disease defined by white matter lesions on MRI

Secondary Outcome Measures

All-cause death

Full Information

First Posted
July 26, 2008
Last Updated
February 23, 2011
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00724724
Brief Title
The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
Acronym
ESCAPE
Official Title
The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
Stroke, Transient Ischemic Attack

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Butylphthalide Soft Capsules + Aspirin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Aspirin
Intervention Type
Drug
Intervention Name(s)
Butylphthalide Soft Capsules
Other Intervention Name(s)
Butylphthalide Soft Capsules, En Bi Pu (NBP)
Intervention Description
Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 100mg Qd for 1 year
Primary Outcome Measure Information:
Title
Newly onset ischemic stroke
Time Frame
1 year follow up
Title
vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
Time Frame
1 year follow up
Title
Small vessel disease defined by white matter lesions on MRI
Time Frame
1 year follow up
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic cerebral infarction or TIA within 90 days. Aged above 40 years old. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases Stable clinical and neurological conditions. Informed consent is obtained. Exclusion Criteria: Intracranial hemorrhage 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 Cardio embolism Patients with anticoagulants treament including heparin or warfarin 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 Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed. A Modified Rankin score is more than 4 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: Concurrent participation in another clinical trial Uncontrolled hypertension : systolic blood pressure greater than 180mmHg, or diastolic blood pressure greater than 100mmHg Haemostatic disorder or thrombocytopenia (i.e., PLT<100×109/l). Currently active peptic ulcer disease Pregnant or breast feeding Planned for major surgery, carotid endarterectomy, or carotid angioplasty Unable to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liying Cui
Phone
86-10-65296373
Email
pumchcly@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shan Gao
Phone
86-10-65296383
Email
dr.sgao@gmail.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liying Cui
Phone
86-10-65296373
Email
pumchcly@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shan Gao
Phone
86-10-65296383
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengyu Jin
Phone
65295441
Facility Name
Peking Union Medical College Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liying Cui
Phone
86-10-65296373
Email
pumchcly@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Bin Peng
Phone
86-10-65296371
Email
pengbin3@hotmail.com
Facility Name
China Pla General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengli Tian
Email
tianchenglin719@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Chengli Tian
Facility Name
Beijing Daxing District Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liuzhuang Zhao
Email
Zlz66@yahoo.com.cn
Facility Name
Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuheng Sun
Email
yuhengs@126.com
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiwen Xu
Email
xhwdoctor@163.com
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zhou
Email
yongzhou78214@163.com
Facility Name
China Rehabilition Research Center
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhao
Email
zaojun@sohu.com
Facility Name
General Hospital of Navy
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaokun Qi
Email
bjqxk@sina.com
Facility Name
Luhe Hospital of Tongzhou Distict Beijing
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huishan Du
Email
smashxk@msn.com
Facility Name
No 263 Hospital of Pla
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinli Zhang
Email
hi1044@163.com
Facility Name
No 309 Hospital of Pla
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuping Chen
Email
leafcyp@163.com
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang
Email
Who626@163.com
Facility Name
Pinggu County Hospital Beijing
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiyun Zhang
Email
pgzhangguiyun@2008.sina.com
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Jia
Email
jiajp@vip.sina.com
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huadong Zhou
Email
Zhouhuadong@163.com
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shugui Shi
Email
southwestneuro@163.com
Facility Name
Guangzhou First Municipal People'S Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengyan Li
Facility Name
The First Affiliated Hospital,Sun Yat-Sen Unversity
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Hong
Email
hhsums@163.com
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingwei Wang
Email
wmw@hebmu.edu.cn
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenzhong Li
Email
johndoctor@126.com
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junyan Liu
Email
junyanliu2003@yahoo.com.cn
Facility Name
Yutian County Hospital
City
Yutian
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinchao Wang
Phone
86-0315-6158126
Facility Name
Hebei North University
City
Zhangjiakou
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shumin Yue
Email
yuesm6903@sina.com
Facility Name
The First Hospital of Harbin Medical University
City
Harbin
State/Province
Helongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weizhi Wang
Email
wwz_h2008@yahoo.com.cn
Facility Name
The Second Hospital of Harbin Medical University
City
Harbin
State/Province
Helongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Zhang
Email
zfx001@yahoo.com
Facility Name
Henan Provincial People'S Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiewen Zhang
Email
zhangjiewen9900@126.com
Facility Name
The Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjian Zhang
Email
wdsjkx@yahoo.com.cn
Facility Name
Xiangya Hospital of Centre-South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xia
Email
xiajian1216@sina.com
Facility Name
Inner Mongolia Baotou City Central Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Zhang
Email
zhangjingfen@263.sina.com
Facility Name
The Appurtenant Hospital of Chifeng University
City
Chifeng
State/Province
Inner Mongolia
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifu Cui
Email
Cxb1986@sina.com
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinsheng Ding
Email
xsding@publicl.ptt.js.cn
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gelin Xu
Email
gelinxu@gmail.com
Facility Name
The Affiliated Drumtower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xu
Email
xuyun20042001@yahoo.com.cn
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Cao
Email
yongjuncao@yahoo.com.cn
Facility Name
Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Wu
Email
sjnkwujing@sina.com
Facility Name
The Third People'S Hospital of Dalian
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingbo Zhang
Email
dlzhangjingbo@163.com
Facility Name
The First Affiliated Hospital of China Medical Sciences University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaodong Zhang
Email
xczhang@163.com
Facility Name
Qinghai Provincial People'S Hospital
City
Xining
State/Province
Qinghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinpeng Wang
Email
qhwjp@yahoo.com.cn
Facility Name
Qilu Hospital of Shangdong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuzhen Wang
Email
xxwsz63@yahoo.com.cn
Facility Name
The Second Hospitalof Shangdong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Shang
Email
wshang85@yahoo.com.cn
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang
Email
autum88_cn@yahoo.com
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Chen
Email
abilitywin@163.com
Facility Name
West China Center of Medical Sciences
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Zhou
Email
zhoudong66@yahoo.de
Facility Name
The General Hospital Under Tianjin Medical Sciences University
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Cheng
Email
cylfl@sohu.com
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhecheng Zhang
Email
zzc0912@yahoo.com.cn
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Uramuqi
State/Province
Xinjiang uygur autonomous region
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoning Zhang
Email
zxn-1960@163.com
Facility Name
Second Affiliated Hospital Zhejiang University College of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiping Ding
Email
yichen@mail.hz.zj.cn
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwen Wang
Email
warrington@126.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs