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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT00724724
First received: July 26, 2008
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Stroke
Transient Ischemic Attack
Drug: Butylphthalide Soft Capsules
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Newly onset ischemic stroke [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
  • vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
  • Small vessel disease defined by white matter lesions on MRI [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause death [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: August 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Aspirin
Drug: Aspirin
Aspirin 100mg Qd for 1 year

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724724

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

  Show 50 Study Locations
Sponsors and Collaborators
Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Liying Cui, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00724724     History of Changes
Other Study ID Numbers: 2006BAI01A10-3
Study First Received: July 26, 2008
Last Updated: February 23, 2011
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Stroke
Transient Ischemic Attack

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Aspirin
3-n-butylphthalide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014