A Multiple-Centered, Prospective Cohort Study: the Second Prevention Trial for Ischemic Stroke With Deng Zhan Sheng Mai Capsule（SPIRIT-DZSM-2）
A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
1 other identifier
interventional
12,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2007
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 22, 2007
CompletedFirst Posted
Study publicly available on registry
October 23, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedOctober 30, 2007
October 1, 2007
October 22, 2007
October 28, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence of stroke
1 year
Secondary Outcomes (1)
Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)
1 year
Study Arms (1)
1
EXPERIMENTALdrug
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Huang, Bachelor
Guangdong Province Hospital of Tradtional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 22, 2007
First Posted
October 23, 2007
Study Start
November 1, 2007
Study Completion
October 1, 2009
Last Updated
October 30, 2007
Record last verified: 2007-10