The Secondary Prevention of Nonvalvular Atrial Fibrillation Patients With an Initial Cardioembolic Stroke "CE"

Recruiting

Phase 3 Results N/A

Trial Description

The Secondary Prevention of patients with an initial cardioembolic stroke associated with nonvalvular atrial fibrillation.

Detailed Description

For the patients with stroke associated with atrial fibrillation,the guidelines recommend warfarin as the secondary prevention,but it's disadvantages such as the narrow safety scope,high bleeding risk hinder it's utilization in clinical.We divide our trial into two groups, the experimental group is aspirin plus Hirudin,the control group is warfarin.We aim at comparing two groups'efficacy and safety difference in secondary prevention of atrial fibrillation combined stroke.

Conditions

Interventions

  • Warfarin (Coumadin®)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: An initial dose of Warfarin is 1.5mg,once daily. 3 days later,we check the international normalized ratio(INR) values​​ and adjust the warfarin dose make INR between 2-3 steady.Then, we maintain this warfarin dose.
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: Warfarin group was given 14-21 days after the onset of oral warfarin, an initial dose of 1.5mg, 1 day, 3 days to check international normalized ratio values​​, warfarin dosage adjustments until international normalized ratio stable in the 2.0-3.0 range, and thereafter maintain this dose, monthly review of international normalized ratio, adjust the dosage.
  • Aspirin and hirudin Drug
    Other Names: aspirin and hirudin
    Intervention Desc: hirudin capsules every two, three times a day, every aspirin 100mg, once daily.
    ARM 1: Kind: Experimental
    Label: aspirin and hirudin
    Description: In the aspirin and hirudin treatment group 14-21 days after the onset of hirudin given aspirin enteric-coated tablets and capsules for oral, hirudin capsules every two, three times a day, every aspirin 100mg, once daily.
  • Aspirin plus hirudin Drug
    Other Names: aspirin plus hirudin
    Intervention Desc: hirudin two tables, three times a day and aspirin 100mg, once daily.
    ARM 1: Kind: Experimental
    Label: aspirin plus hirudin
    Description: 14 days after stroke occurred, the experimental group gives hirudin two tables three times a day and aspirin 100mg, once daily.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The recurrence of cardioembolic stroke up to one year after onset No
Secondary Other ischemic cerebrovascular disease one year after onset No

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