ARTSS-2
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
IRAS ID
102972
Contact name
Gary Ford
Sponsor organisation
University of Texas Health Science Center
Eudract number
2012-002319-25
Clinicaltrials.gov 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
12/NW/0425
Date of REC Opinion
24 Jul 2012
REC opinion
Further Information Favourable Opinion