CClinicalTrials.gg
Status unknownNCT00724724ESCAPEUpdated Feb 24, 2011

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

A Phase 4 interventional study of Butylphthalide Soft Capsules and Aspirin in Stroke and Transient Ischemic Attack, sponsored by Peking Union Medical College Hospital. Status unknown at 50 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-02-24.

Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke
  • Transient Ischemic Attack

Keywords

  • Stroke
  • Transient Ischemic Attack
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    1

    Butylphthalide Soft Capsules + Aspirin

    Drug: Butylphthalide Soft Capsules

  • Active comparator
    2

    Aspirin

    Drug: Aspirin

Interventions

  • DrugButylphthalide Soft Capsules

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

    Also known as: Butylphthalide Soft Capsules, En Bi Pu (NBP)

  • DrugAspirin

    Aspirin 100mg Qd for 1 year

06

What researchers measure

Primary outcomes

  1. Newly onset ischemic stroke

    Time frame: 1 year follow up

  2. vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery

    Time frame: 1 year follow up

  3. Small vessel disease defined by white matter lesions on MRI

    Time frame: 1 year follow up

Secondary outcomes

  1. All-cause death

    Time frame: 1 year follow up

07

Study locations

3 of 50 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Not yet recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    • Zhengyu Jin · Contact · 65295441
    Not yet recruiting
  • Peking Union Medical College Hosptial
    Beijing, Beijing 100730, China
    Not yet recruiting
  • China Pla General Hospital
    Beijing, Beijing 100853, China
    Not yet recruiting
  • Beijing Daxing District Hospital
    Beijing, Beijing, China
    Not yet recruiting
  • Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University
    Beijing, Beijing, China
    Not yet recruiting
  • Beijing Shijitan Hospital
    Beijing, Beijing, China
    Recruiting
  • Beijing Tiantan Hospital
    Beijing, Beijing, China
    Not yet recruiting
  • China Rehabilition Research Center
    Beijing, Beijing, China
    Not yet recruiting
  • General Hospital of Navy
    Beijing, Beijing, China
    Not yet recruiting
  • Luhe Hospital of Tongzhou Distict Beijing
    Beijing, Beijing, China
    Not yet recruiting
  • No 263 Hospital of Pla
    Beijing, Beijing, China
    Not yet recruiting
  • No 309 Hospital of Pla
    Beijing, Beijing, China
    Not yet recruiting
  • Peking University Third Hospital
    Beijing, Beijing, China
    Not yet recruiting
  • Pinggu County Hospital Beijing
    Beijing, Beijing, China
    Not yet recruiting
  • Xuanwu Hospital Capital Medical University
    Beijing, Beijing, China
    Not yet recruiting
  • Daping Hospital
    Chongqing, Chongqing, China
    Not yet recruiting
  • Southwest Hospital
    Chongqing, Chongqing, China
    Not yet recruiting
  • Guangzhou First Municipal People'S Hospital
    Guangzhou, Guangdong, China
    • Mengyan Li · Contact
    Not yet recruiting
  • The First Affiliated Hospital,Sun Yat-Sen Unversity
    Guangzhou, Guangdong, China
    Not yet recruiting
  • The First Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
    Not yet recruiting
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
    Not yet recruiting
  • The Third Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
    Not yet recruiting
  • Yutian County Hospital
    Yutian, Hebei, China
    • Jinchao Wang · Contact · 86-0315-6158126
    Not yet recruiting
  • Hebei North University
    Zhangjiakou, Hebei, China
    Not yet recruiting
  • The First Hospital of Harbin Medical University
    Harbin, Helongjiang, China
    Not yet recruiting
  • The Second Hospital of Harbin Medical University
    Harbin, Helongjiang, China
    Not yet recruiting
  • Henan Provincial People'S Hospital
    Zhengzhou, Henan, China
    Not yet recruiting
  • The Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, China
    Not yet recruiting
  • Xiangya Hospital of Centre-South University
    Changsha, Hunan, China
    Not yet recruiting
  • Inner Mongolia Baotou City Central Hospital
    Baotou, Inner Mongolia, China
    Not yet recruiting
  • The Appurtenant Hospital of Chifeng University
    Chifeng, Inner Mongolia, China
    Not yet recruiting
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
    Not yet recruiting
  • Nanjing General Hospital of Nanjing Military Command
    Nanjing, Jiangsu, China
    Not yet recruiting
  • The Affiliated Drumtower Hospital of Nanjing University Medical School
    Nanjing, Jiangsu, China
    Not yet recruiting
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
    Not yet recruiting
  • Jilin University
    Changchun, Jilin, China
    Not yet recruiting
  • The Third People'S Hospital of Dalian
    Dalian, Liaoning, China
    Recruiting
  • The First Affiliated Hospital of China Medical Sciences University
    Shenyang, Liaoning, China
    Not yet recruiting
  • Qinghai Provincial People'S Hospital
    Xining, Qinghai, China
    Not yet recruiting
  • Qilu Hospital of Shangdong University
    Jinan, Shandong, China
    Not yet recruiting
  • The Second Hospitalof Shangdong University
    Jinan, Shandong, China
    Not yet recruiting
  • Huashan Hospital Fudan University
    Shanghai, Shanghai, China
    Not yet recruiting
  • Shanghai Changzheng Hospital
    Shanghai, Shanghai, China
    Not yet recruiting
  • West China Center of Medical Sciences
    Chengdu, Sichuan, China
    Not yet recruiting
  • The General Hospital Under Tianjin Medical Sciences University
    Tianjin, Tianjin, China
    Recruiting
  • Tianjin Third Central Hospital
    Tianjin, Tianjin, China
    Not yet recruiting
  • First Affiliated Hospital of Xinjiang Medical University
    Uramuqi, Xinjiang uygur autonomous region, China
    Not yet recruiting
  • Second Affiliated Hospital Zhejiang University College of Medicine
    Hangzhou, Zhejiang, China
    Not yet recruiting
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
    Hangzhou, Zhejiang, China
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00724724
Lead sponsor
Peking Union Medical College Hospital
First posted
Jul 29, 2008
Start date
Aug 2008
Primary completion
Jun 2011 (estimated)
Completion
Aug 2011 (estimated)
Last update
Feb 24, 2011

Study contacts

Liying Cui
Contact
pumchcly@yahoo.com.cn
86-10-65296373
Shan Gao
Contact
dr.sgao@gmail.com
86-10-65296383

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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