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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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