A Multiple-Centered, Prospective Cohort Study: the Second Prevention Trial for Ischemic Stroke With Deng Zhan Sheng Mai Capsule（SPIRIT—DZSM-2）

Ischemic Stroke Clinical Trial

Official title:

A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00547950
• Other study ID #: 2006BAI04A02-2
• Status: Not yet recruiting
• Phase: N/A
• First received: October 22, 2007
• Last updated: October 28, 2007
• Start date: November 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2007
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Yan Huang, Bachelor
• Phone: (08620) 81887233
• Email: huang61[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. From November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai capsule or not. The basic therapy included antiplatelet aggregation , stroke health education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the subjects are visited on the 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12000
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 40-75 years old

• Ischemic stroke diagnosed by CT/MRI scan

• Patient presenting from 14 days to 6 months of first onset of Ischemic stroke.

• Presence of at least one risk factor of stroke (such as hypertension, Diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.)that can be interfered in.

• Informed consent.

Exclusion Criteria:

• Silent cerebral infarction;

• Patients after vasculoplasty with Intracranial Artery Stenosis.

• Watian drinking test=grade 4.

• MRS=grade 5.

• Cerebral infarction due to other causes except arterial Sclerosis(i.e. cardiogenic embolism, arteritis, polycythemia vera, primary thrombocythemia, sickle-cell anemia,, thrombotic thrombocytopenia purpura, DIC, cerebral amyloid angiopathy, Moyamoya disease, intracranial vascular malformations etc);

• Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage;

• Patients with mental disorder.

• Patients that cannot take medicine due to other causes

• Females during pregnancy or lactation.

• Already attend other clinical trial.

• That unsuitable for clinical trial.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• :Deng Zhan Sheng Mai Capsule
capsule,0.18g,2#,po,Bid*1year.

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Tradtional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of stroke		1 year
Secondary	Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)		1 year