StrokePhase 4ESCAPENCT00724724
The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
A Phase 4 study testing Butylphthalide Soft Capsules and Aspirin in people with Stroke and Transient Ischemic Attack, run by Peking Union Medical College Hospital at 50 sites in China.
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 Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Butylphthalide Soft Capsules and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 50 sitesChina
- Study dates
- Aug 2008to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
China50 sites, 50 recruiting
- Not yet recruiting
Inner Mongolia Baotou City Central Hospital
Baotou, Inner Mongolia
Jingfen Zhang, zhangjingfen@263.sina.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Liying Cui, 86-10-65296373, pumchcly@yahoo.com.cn
Shan Gao, 86-10-65296383
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhengyu Jin, 65295441
- Not yet recruiting
Peking Union Medical College Hosptial
Beijing, Beijing Municipality, 100730
Liying Cui, 86-10-65296373, pumchcly@yahoo.com.cn
Bin Peng, 86-10-65296371, pengbin3@hotmail.com
- Not yet recruiting
China Pla General Hospital
Beijing, Beijing Municipality, 100853
Chengli Tian, tianchenglin719@yahoo.com.cn
Chengli Tian
- Not yet recruiting
Beijing Daxing District Hospital
Beijing, Beijing Municipality
Liuzhuang Zhao, Zlz66@yahoo.com.cn
- Not yet recruiting
Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
Beijing, Beijing Municipality
Yuheng Sun, yuhengs@126.com
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality
Huiwen Xu, xhwdoctor@163.com
- Not yet recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Yong Zhou, yongzhou78214@163.com
- Not yet recruiting
China Rehabilition Research Center
Beijing, Beijing Municipality
Jun Zhao, zaojun@sohu.com
- Not yet recruiting
General Hospital of Navy
Beijing, Beijing Municipality
Xiaokun Qi, bjqxk@sina.com
- Not yet recruiting
Luhe Hospital of Tongzhou Distict Beijing
Beijing, Beijing Municipality
Huishan Du, smashxk@msn.com
- Not yet recruiting
No 263 Hospital of Pla
Beijing, Beijing Municipality
Jinli Zhang, hi1044@163.com
- Not yet recruiting
No 309 Hospital of Pla
Beijing, Beijing Municipality
Yuping Chen, leafcyp@163.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Jun Zhang, Who626@163.com
- Not yet recruiting
Pinggu County Hospital Beijing
Beijing, Beijing Municipality
Guiyun Zhang, pgzhangguiyun@2008.sina.com
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Jianping Jia, jiajp@vip.sina.com
- Not yet recruiting
Jilin University
Changchun, Jilin
Jiang Wu, sjnkwujing@sina.com
- Not yet recruiting
Xiangya Hospital of Centre-South University
Changsha, Hunan
Jian Xia, xiajian1216@sina.com
- Not yet recruiting
West China Center of Medical Sciences
Chengdu, Sichuan
Dong Zhou, zhoudong66@yahoo.de
- Not yet recruiting
The Appurtenant Hospital of Chifeng University
Chifeng, Inner Mongolia
Qifu Cui, Cxb1986@sina.com
- Not yet recruiting
Daping Hospital
Chongqing, Chongqing Municipality
Huadong Zhou, Zhouhuadong@163.com
- Not yet recruiting
Southwest Hospital
Chongqing, Chongqing Municipality
Shugui Shi, southwestneuro@163.com
- Recruiting
The Third People'S Hospital of Dalian
Dalian, Liaoning
Jingbo Zhang, dlzhangjingbo@163.com
- Not yet recruiting
Guangzhou First Municipal People'S Hospital
Guangzhou, Guangdong
Mengyan Li
- Not yet recruiting
The First Affiliated Hospital,Sun Yat-Sen Unversity
Guangzhou, Guangdong
Hua Hong, hhsums@163.com
- Not yet recruiting
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang
Meiping Ding, yichen@mail.hz.zj.cn
- Not yet recruiting
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jianwen Wang, warrington@126.com
- Not yet recruiting
The First Hospital of Harbin Medical University
Harbin, Helongjiang
Weizhi Wang, wwz_h2008@yahoo.com.cn
- Not yet recruiting
The Second Hospital of Harbin Medical University
Harbin, Helongjiang
Liming Zhang, zfx001@yahoo.com
- Not yet recruiting
Qilu Hospital of Shangdong University
Jinan, Shandong
Shuzhen Wang, xxwsz63@yahoo.com.cn
- Not yet recruiting
The Second Hospitalof Shangdong University
Jinan, Shandong
Wei Shang, wshang85@yahoo.com.cn
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Xinsheng Ding, xsding@publicl.ptt.js.cn
- Not yet recruiting
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu
Gelin Xu, gelinxu@gmail.com
- Not yet recruiting
The Affiliated Drumtower Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Yun Xu, xuyun20042001@yahoo.com.cn
- Not yet recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Liang Wang, autum88_cn@yahoo.com
- Not yet recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Xiaoyan Chen, abilitywin@163.com
- Not yet recruiting
The First Affiliated Hospital of China Medical Sciences University
Shenyang, Liaoning
Chaodong Zhang, xczhang@163.com
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Mingwei Wang, wmw@hebmu.edu.cn
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zhenzhong Li, johndoctor@126.com
- Not yet recruiting
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Junyan Liu, junyanliu2003@yahoo.com.cn
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Yongjun Cao, yongjuncao@yahoo.com.cn
- Recruiting
The General Hospital Under Tianjin Medical Sciences University
Tianjin, Tianjin Municipality
Yan Cheng, cylfl@sohu.com
- Not yet recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality
Zhecheng Zhang, zzc0912@yahoo.com.cn
- Not yet recruiting
First Affiliated Hospital of Xinjiang Medical University
Uramuqi, Xinjiang Uygur Autonomous Region
Xiaoning Zhang, zxn-1960@163.com
- Not yet recruiting
The Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Junjian Zhang, wdsjkx@yahoo.com.cn
- Not yet recruiting
Qinghai Provincial People'S Hospital
Xining, Qinghai
Jinpeng Wang, qhwjp@yahoo.com.cn
- Not yet recruiting
Yutian County Hospital
Yutian, Hebei
Jinchao Wang, 86-0315-6158126
- Not yet recruiting
Hebei North University
Zhangjiakou, Hebei
Shumin Yue, yuesm6903@sina.com
- Not yet recruiting
Henan Provincial People'S Hospital
Zhengzhou, Henan
Jiewen Zhang, zhangjiewen9900@126.com
About this study
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
Read the 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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Butylphthalide Soft Capsules, Aspirin
- Keywords
- Stroke, Transient Ischemic Attack
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butylphthalide Soft CapsulesDrug
Also called Butylphthalide Soft Capsules, En Bi Pu (NBP)
Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
AspirinDrug
Aspirin 100mg Qd for 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Butylphthalide Soft Capsules + Aspirin Receives: Drug: Butylphthalide Soft Capsules |
| 2 | Active comparator | Aspirin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly onset ischemic stroke
Measured: 1 year follow up
vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
Measured: 1 year follow up
Small vessel disease defined by white matter lesions on MRI
Measured: 1 year follow up
Secondary outcomes (1)
All-cause death
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724724
- Sponsor's protocol ID
- 2006BAI01A10-3
- Acronym
- ESCAPE
- Status last verified
- Feb 2011
- First submitted
- 26 Jul 2008
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
- ClinicalTrials.gov ID
- NCT00724724
- Acronym / sponsor ID
- ESCAPE / 2006BAI01A10-3
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- Stroke, Transient Ischemic Attack
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Butylphthalide Soft CapsulesButylphthalide Soft Capsules + Aspirin |
| 2 | Active comparator | Drug: AspirinAspirin |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butylphthalide Soft CapsulesAlso: Butylphthalide Soft Capsules, En Bi Pu (NBP)Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year | Drug | 1 |
| AspirinAspirin 100mg Qd for 1 year | Drug | 2 |
Primary outcome
Newly onset ischemic stroke
Time frame: 1 year follow up
vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
Time frame: 1 year follow up
Small vessel disease defined by white matter lesions on MRI
Time frame: 1 year follow up
1 secondary outcome
All-cause death
Time frame: 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Butylphthalide Soft Capsules and Aspirin in people with Stroke and Transient Ischemic Attack, run by Peking Union Medical College Hospital at 50 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liying Cui (86-10-65296373, pumchcly@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newly onset ischemic stroke (time frame: 1 year follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.