• Research type

    Research Study

  • Full title

    A pilot, phase IIb, randomised, multicentre trial of Argatroban in combination with recombinant tissue plasminogen activator for acute stroke



  • Contact name

    Gary Ford

  • Sponsor organisation

    University of Texas Health Science Center

  • Eudract number


  • Identifier


  • Research summary

    ARTSS-2 - A pilot, phase IIb, randomised, multi-centre trial of Argatroban in combination with recombinant tissue plasminogen activator for acute stroke. Recombinant tissue plasminogen activator (rt-PA), the only proven treatment for acute ischemic stroke, fails to reperfuse the brain in most patients with large thrombi. In a Phase IIa low-dose safety study (n=65), conducted by University of Texas-Houston, delivering Argatroban with rt-PA indicated that both drugs appear safe when delivered concomitantly and recanalisation rates were greater than with historical controls. The purpose of the trial is to estimate the overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA (Alteplase) who are randomised to receive either low-dose Argatroban, high-dose Argatroban or neither. This study will provide evidence-based hypotheses and data needed to design a larger definitive trial. The study will be conducted in six hospitals across the UK and will recruit males and females over 18 years of age with acute ischemic stroke. During the course of the treatment, patients will be evaluated via CT angiogram, CT scans, vital signs, laboratory measurements, and neurological and functional outcomes. Patients will also be evaluated at 24 hours following the onset of the stroke, Day 7 or discharge (whichever comes first) and at day 90.

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    24 Jul 2012

  • REC opinion

    Further Information Favourable Opinion