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

Primary Purpose

Ischemic Stroke

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

:Deng Zhan Sheng Mai Capsule

About this trial

This is an interventional prevention trial for Ischemic Stroke

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Guangdong Province Hospital of Tradtional Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

drug

Outcomes

Primary Outcome Measures

recurrence of stroke

Secondary Outcome Measures

Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)

Full Information

NCT ID

NCT00547950

First Posted

October 22, 2007

Last Updated

October 28, 2007

Sponsor

Guangzhou University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00547950

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

drug

Intervention Type

Drug

Intervention Name(s)

:Deng Zhan Sheng Mai Capsule

Intervention Description

capsule，0.18g，2＃，po，Bid*1year.

Primary Outcome Measure Information:

Title

recurrence of stroke

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Huang, Bachelor

Phone

(08620) 81887233

Ext

34530

huang61@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

LIxin Wang, Doctor

Phone

(08620) 81887233

Ext

34530

plawlx@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Huang, Bachelor

Organizational Affiliation

Guangdong Province Hospital of Tradtional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong Province Hospital of Tradtional Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lixin Wang, Doctor

Phone

(08620)81887233

Ext

34530

plawlx@126.com

First Name & Middle Initial & Last Name & Degree

Yan Huang, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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