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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,000

participants targeted

Target at P75+ for phase_4 stroke

Timeline

Completed

Started Aug 2008

Typical duration for phase_4 stroke

Geographic Reach

1 country

50 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

July 26, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed

3 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed

Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

2.8 years

First QC Date

July 26, 2008

Last Update Submit

February 23, 2011

Conditions

Stroke Transient Ischemic Attack

Keywords

StrokeTransient Ischemic Attack

Outcome Measures

Primary Outcomes (3)

Newly onset ischemic stroke
1 year follow up
vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery
1 year follow up
Small vessel disease defined by white matter lesions on MRI
1 year follow up

Secondary Outcomes (1)

All-cause death
1 year follow up

Study Arms (2)

1

EXPERIMENTAL

Butylphthalide Soft Capsules + Aspirin

Drug: Butylphthalide Soft Capsules

2

ACTIVE COMPARATOR

Aspirin

Drug: Aspirin

Interventions

Butylphthalide Soft CapsulesDRUG

Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year

Also known as: Butylphthalide Soft Capsules, En Bi Pu (NBP)

AspirinDRUG

Aspirin 100mg Qd for 1 year

Eligibility Criteria

Age40 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ischemic cerebral infarction or TIA within 90 days.
Aged above 40 years old.
Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
Stable clinical and neurological conditions.
Informed consent is obtained.

You may not qualify if:

Intracranial hemorrhage
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
Cardio embolism
Patients with anticoagulants treament including heparin or warfarin
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
Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
A Modified Rankin score is more than 4
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:
Concurrent participation in another clinical trial
Uncontrolled hypertension : systolic blood pressure greater than 180mmHg, or diastolic blood pressure greater than 100mmHg
Haemostatic disorder or thrombocytopenia (i.e., PLT\<100×109/l).
Currently active peptic ulcer disease
Pregnant or breast feeding
Planned for major surgery, carotid endarterectomy, or carotid angioplasty
Unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Union Medical College Hospitallead

Study Sites (50)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Peking Union Medical College Hosptial

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

China Pla General Hospital

Beijing, Beijing Municipality, 100853, China

NOT YET RECRUITING

Beijing Daxing District Hospital