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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • :Deng Zhan Sheng Mai Capsule Drug
    Intervention Desc: capsule,0.18g,2#,po,Bid*1year.
    ARM 1: Kind: Experimental
    Label: 1
    Description: drug

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary recurrence of stroke 1 year
Secondary Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS) 1 year

Sponsors