Therapy Registry for Chinese Ischemic Stroke Within 6 h Onset "TRECIS"

Not yet recruiting

Phase N/A Results N/A

Trial Description

Stroke is one of the leading causes of death and disability in China. Intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010 Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke, and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is used more frequently than rt-PA, mainly because it is cheaper. Defibrase is a purified protein extracted from venin. defibrase appears safe and effective in the treatment of acute ischaemic stroke by several large sample,multicenter, randomized,double-blind, and placebo-controlled clinical trial. For patients with acute ischaemic stroke, which is not suitable for thrombolysis and after cases selected, especially those with high plasma fibrinogen, it can be used in the treatment of defibrase. To describe Chinese experience with thrombolytic therapy for Ischemic Stroke within 6 h onset, we designed a multicenter, prospective, registry study. The aim of Therapy REgistry for Chinese Ischemic Stroke within 6 h onset(TRECIS)was to assess the safety and efficacy of intravenous rtPA, urokinase or defibrase as thrombolytic therapy within the first 6 h of onset of acute ischaemic stroke.

Detailed Description

TRECIS is a prospective multicenter registry using data from 60 centres in the Northeast China. Consecutive patients with acute ischemic stroke who are treated with intravenous rtPA, urokinase or defibrase within 6 hours of symptom onset in 60 centres of the Northeast China will be eligible for this registry. Patient involvement in the registry shall not influence any treatment decision. Patients will undergo a complete diagnostic work up including a clinical neurological examination using the National Institutes of Health Stroke Scale (NIHSS) score, laboratory examination, brain and neurovascular imaging, echocardiography, 24-hours ECG. Clinical outcome will be evaluated on day 1 and day 14 using the National Institute of Health Stroke Scale (NIHSS) score, evaluated at 3 months and on 1 year using modified Rankin Scale score (mRS) and assessing adverse events. The proportion of patients with favourable outcome (mRS 0 to 2) at 3 months after treatment will serve as the primary outcome measure. Secondary outcome measures will include unfavourable clinical outcome (mRS 3 to 6), NIHSS reported and mortality.

Conditions

Interventions

  • Urokinase (Abbokinase®)Drug
    Intervention Desc: intravenous thrombolysis with urokinase
    ARM 1: Kind: Experimental
    Label: urokinase
    Description: 1,500,000 units of urokinase intravenous infused over 30 minutes within 6 h of stroke onset .
  • RtPA Drug
    Other Names: alteplase
    Intervention Desc: intravenous thrombolysis with rtPa
    ARM 1: Kind: Experimental
    Label: rtPA
    Description: Intravenous rt-PA thrombolysis shall be administered within 4.5 h after symptom onset, at a dose of 0.9 mg/kg body weight (maximum, 90 mg), with 10% of the dose given as a bolus over 1 min and the remaining 90% infused over 60 min.
  • Defibrase Drug
    Intervention Desc: intravenous infusion with defibrase
    ARM 1: Kind: Experimental
    Label: defibrase
    Description: an initial intravenous infusion of defibrase 10 U within 24 hours of stroke onset. Subsequent infusions of defibrase 5 U is given on the third and the fifth day respectively.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients with acute ischemic stroke within 6 hours of symptom onset

Outcomes

Type Measure Time Frame Safety Issue
Primary favourable outcome 90 days No
Secondary unfavourable outcome 90 days No
Secondary intracranial haemorrhages 1 day, 14 days, 90 days Yes
Secondary New stroke 1 year No
Secondary mortality 1 day, 14 days, 90 days, 1years Yes
Secondary NIHSS score 1 day, 14 days No

Sponsors