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

February 23, 2011 updated by: Peking Union Medical College Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Butylphthalide Soft Capsules + Aspirin
Drug: Butylphthalide Soft Capsules
Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
Other Names:
  • Butylphthalide Soft Capsules, En Bi Pu (NBP)
ACTIVE_COMPARATOR: 2
Aspirin
Drug: Aspirin
Aspirin 100mg Qd for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Newly onset ischemic stroke
Time Frame: 1 year follow up
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
1 year follow up
Small vessel disease defined by white matter lesions on MRI
Time Frame: 1 year follow up
1 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: 1 year follow up
1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

August 1, 2011

Study Registration Dates

First Submitted

July 26, 2008

First Submitted That Met QC Criteria

July 26, 2008

First Posted (ESTIMATE)

July 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI01A10-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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