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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00724724
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 50
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2008
• Anticipated Primary Completion Date: Jun 1, 2011
• Anticipated Study Completion Date: Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Newly onset ischemic stroke [1 year follow up]

2. vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery [1 year follow up]

3. Small vessel disease defined by white matter lesions on MRI [1 year follow up]

Secondary Outcome Measures

1. All-cause death [1 year follow up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
3	Peking Union Medical College Hosptial	Beijing	Beijing	China	100730
4	China Pla General Hospital	Beijing	Beijing	China	100853
5	Beijing Daxing District Hospital	Beijing	Beijing	China
6	Beijing Ji Shui Tan Hospital,the 4Th Medical College of Peking University	Beijing	Beijing	China
7	Beijing Shijitan Hospital	Beijing	Beijing	China
8	Beijing Tiantan Hospital	Beijing	Beijing	China
9	China Rehabilition Research Center	Beijing	Beijing	China
10	General Hospital of Navy	Beijing	Beijing	China
11	Luhe Hospital of Tongzhou Distict Beijing	Beijing	Beijing	China
12	No 263 Hospital of Pla	Beijing	Beijing	China
13	No 309 Hospital of Pla	Beijing	Beijing	China
14	Peking University Third Hospital	Beijing	Beijing	China
15	Pinggu County Hospital Beijing	Beijing	Beijing	China
16	Xuanwu Hospital Capital Medical University	Beijing	Beijing	China
17	Daping Hospital	Chongqing	Chongqing	China
18	Southwest Hospital	Chongqing	Chongqing	China
19	Guangzhou First Municipal People'S Hospital	Guangzhou	Guangdong	China
20	The First Affiliated Hospital,Sun Yat-Sen Unversity	Guangzhou	Guangdong	China
21	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
22	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
23	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
24	Yutian County Hospital	Yutian	Hebei	China
25	Hebei North University	Zhangjiakou	Hebei	China
26	The First Hospital of Harbin Medical University	Harbin	Helongjiang	China
27	The Second Hospital of Harbin Medical University	Harbin	Helongjiang	China
28	Henan Provincial People'S Hospital	Zhengzhou	Henan	China
29	The Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China
30	Xiangya Hospital of Centre-South University	Changsha	Hunan	China
31	Inner Mongolia Baotou City Central Hospital	Baotou	Inner Mongolia	China
32	The Appurtenant Hospital of Chifeng University	Chifeng	Inner Mongolia	China
33	Jiangsu Province Hospital	Nanjing	Jiangsu	China
34	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu	China
35	The Affiliated Drumtower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China
36	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China
37	Jilin University	Changchun	Jilin	China
38	The Third People'S Hospital of Dalian	Dalian	Liaoning	China
39	The First Affiliated Hospital of China Medical Sciences University	Shenyang	Liaoning	China
40	Qinghai Provincial People'S Hospital	Xining	Qinghai	China
41	Qilu Hospital of Shangdong University	Jinan	Shandong	China
42	The Second Hospitalof Shangdong University	Jinan	Shandong	China
43	Huashan Hospital Fudan University	Shanghai	Shanghai	China
44	Shanghai Changzheng Hospital	Shanghai	Shanghai	China
45	West China Center of Medical Sciences	Chengdu	Sichuan	China
46	The General Hospital Under Tianjin Medical Sciences University	Tianjin	Tianjin	China
47	Tianjin Third Central Hospital	Tianjin	Tianjin	China
48	First Affiliated Hospital of Xinjiang Medical University	Uramuqi	Xinjiang uygur autonomous region	China
49	Second Affiliated Hospital Zhejiang University College of Medicine	Hangzhou	Zhejiang	China
50	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00724724
• Other Study ID Numbers: 2006BAI01A10-3
• First Posted: Jul 29, 2008
• Last Update Posted: Feb 24, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Stroke; Transient Ischemic Attack
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia; Aspirin; 3-n-butylphthalide

Study Results

No Results Posted as of Feb 24, 2011