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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00724724
Recruitment Status : Unknown
Verified February 2011 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : July 29, 2008
Last Update Posted : February 24, 2011
Information provided by:
Peking Union Medical College Hospital

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

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Drug: Butylphthalide Soft Capsules Drug: Aspirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial
Study Start Date : August 2008
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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 Name: Butylphthalide Soft Capsules, En Bi Pu (NBP)

Active Comparator: 2
Drug: Aspirin
Aspirin 100mg Qd for 1 year

Primary Outcome Measures :
  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 Outcome Measures :
  1. All-cause death [ Time Frame: 1 year follow up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00724724

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Contact: Liying Cui 86-10-65296373
Contact: Shan Gao 86-10-65296383

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Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Liying Cui, Peking Union Medical College Hospital Identifier: NCT00724724    
Other Study ID Numbers: 2006BAI01A10-3
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011
Keywords provided by Peking Union Medical College Hospital:
Transient Ischemic Attack
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents