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

Guangzhou University of Traditional Chinese Medicine

Status

Unknown

Conditions

Ischemic Stroke

Treatments

Drug: :Deng Zhan Sheng Mai Capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT00547950

2006BAI04A02-2

Details and patient eligibility

About

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.

Enrollment

12,000 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.