Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Background:
Our prior work with combination argatroban + recombinant tissue plasminogen activator (rt-PA)
(ARTSS-1: Phase IIa low-dose safety study; n=65 and ARTSS-2: Phase IIb randomized low and
high-dose study; n=90), demonstrated safety of the two drugs when delivered concomitantly and
recanalization rates were greater than with historical controls. Further, interim analysis of
neurological outcomes at 75 patients of the randomized Phase IIb trial, demonstrated a signal
of efficacy when compared to control (rt-PA alone) patients. However, rt-PA fails to
reperfuse brain in most patients with large thrombi, prompting several recent randomized
clinical trials which have demonstrated that intra-arterial therapy (IA) following rt-PA
substantially improves outcome in patients with distal carotid or proximal middle cerebral
artery occlusions. As a result, rt-PA + IA has become the new standard-of-care for many
patients with large arterial occlusions such as those treated in ARTSS-1 and 2. Therefore,
this study is necessary to explore the feasibility and safety of adding Argatroban in acute
ischemic stroke patients who also receive rt-PA followed by IA.
Primary Objective:
To demonstrate the feasibility and safety of treating stroke patients with Argatroban who
undergo usual thrombolysis care (intravenous rt-PA followed by IA).
Secondary Objectives:
1. Assess rates of ultra-early recanalization at commencement of IA;
2. Assess the completeness and pattern of reperfusion as obtained by IA; 3) Assess clinical
outcome
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston