A Nested Case-control Study on the Secondary Prevention of Ischemic Stroke and TIA by Hypertension Health Education Protocol (HHEP): The Post-Stroke Preventive Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01812421
Recruitment Status : Unknown
Verified April 2013 by Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : March 18, 2013
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine

Brief Summary:

Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are asked to participate in our pre specified hypertension health education protocol (HHEP) after discharge from our hospital.HHEP was used as secondary prevention treatments of stroke and cardiovascular diseases.

HHEP consists of several items such as controlling the patient's hypertension level, monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension like tobacco smoking, obesity, and motivating the patient to physical activity and to a healthy diet.

Patients will receive visits by a study nurse with the aim of supervising, monitoring, and recording the adherence of HHEP. The patients will be classified as different adherence level at the end of the study according to their adherence condition.

This study is aimed at testing the hypothesis that controlling hypertension and its risk factors was more effective than those do not receive HHEP in reducing the recurrence of stroke and cardiovascular diseases.

Condition or disease Intervention/treatment Phase
To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events. Other: Hypertension Health Education Protocol (HHEP) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015

Arm Intervention/treatment
Experimental: Ischemic Stroke or TIA (ISTIA) patients Other: Hypertension Health Education Protocol (HHEP)

Primary Outcome Measures :
  1. Nonfatal vascular events: ischemic or hemorrhagic stroke recurrence (ICD-9 431 or ICD-10 I61), or myocardial infarction(MI) (ICD-9 410 or ICD-10 I21). [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. vascular death (death within 30 days after a vascular event) and all-cause mortality. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Participants were eligible for this observational cohort study if they were age 18 years or older; Hospitalized for a primary diagnosis of acute ischemic stroke or Transient Ischemic Attack (TIA) and concurrently diagnosed as hypertension; Provided consent to participate, and their data can be collected from Medical Record System of our hospital.

Exclusion Criteria:

We will exclude people who are onset of symptoms 3 months after their ischemic stroke or TIA; The stroke events occurred before the baseline survey were identified from the Hospital Discharge Register retrospectively and excluded from the analyses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01812421

Contact: YeFeng Cai, Dr.

China, Guangdong
Brain Center,Guangdong Province Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: YeFeng Cai, Dr.   
Sub-Investigator: ZiYi Zhou, Master         
Sub-Investigator: Lin Wei, Master         
Sub-Investigator: XiaoPei Zhang, Master         
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine

Responsible Party: Guangzhou University of Traditional Chinese Medicine Identifier: NCT01812421     History of Changes
Other Study ID Numbers: B2013-036-01
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes