Brief Summary

The purposes of the study are to analyse the cross-section data of secondary stroke prevention in China and to carry out a standard medical management including medicine and interactive education program,and to evaluate the efficacy and safety of the standard medical management in secondary stroke prevention.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,000

participants targeted

Target at P75+ for not_applicable stroke

Timeline

Completed

Started Apr 2008

Typical duration for not_applicable stroke

Geographic Reach

1 country

46 active sites

Status

completed

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

3 years study duration

Study Start

First participant enrolled

April 1, 2008

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2008

Completed

11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed

Last Updated

April 11, 2011

Status Verified

February 1, 2011

Enrollment Period

2.7 years

First QC Date

April 12, 2008

Last Update Submit

April 8, 2011

Conditions

Stroke

Keywords

StrokePrevention Therapy

Outcome Measures

Primary Outcomes (1)

Success Rate of standard medical management
1 year after enrolled

Secondary Outcomes (5)

Ischemic stroke
1 year after enrolled
Non-fatal acute coronary syndrome
1 year after enrolled
Transient Ischemic Attack
1 year after enrolled
Hemorrhagic Stroke
1 year after enrolled
All-cause Death
1 year after enrolled

Study Arms (2)

1

EXPERIMENTAL

Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin

2

ACTIVE COMPARATOR

Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin

Interventions

Aspirin / Clopidogrel, Atorvastatin / SimvastatinDRUG

Standard Medical Management,including antiplatelet agents(Aspirin 75\~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) .

Asprin / Clopidogrel, Atorvastatin / SimvastatinDRUG

Antiplatelet agents(Aspirin 75\~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ischemic cerebral infarction or TIA within 30 days.
Aged above 18 years old.
Hospitalized.
Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
Stable clinical and neurological conditions.
A Modified Rankin score less than 4 at enrollment
Informed consent is obtained.

You may not qualify if:

Patients will be excluded from entry if any of the criteria listed below are met
Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure.
Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
A Modified Rankin score is more than 4
Concurrent participation in another clinical trial
Pregnant
Unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Union Medical College Hospitallead

Study Sites (46)

Peking Union Medical College Hosptial

Beijing, Beijing Municipality, 100730, China

Location

China Pla General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Beijing Daxing District Hospital