ARTSS-IA: A Pilot, Phase IIa, Safety and Feasibility Study of ARgatroban in Combination With Recombinant Tissue Plasminogen Activator Stroke Study - Intra-Arterial

NCT02448069 Phase 2 COMPLETED

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

Details

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 2
Status	COMPLETED
Enrolment	10
Start date	2015-05
Completion	2016-08

Conditions

• Stroke
• Cerebral Ischemia

Interventions

• Argatroban

Primary outcomes

• Safety as measured by the incidence (absolute number) of symptomatic intracranial hemorrhage (sICH) — 12-36 hours after rt-PA bolus.
  defined as: 1. Any evidence of bleeding on brain imaging that is associated with clinically significant neurological worsening (Greater or equals 4 NIH stroke scale points) and 2. Parenchymal Hemorrhage 2 (PH-2); evidence of confluent hemorrhage on brain imaging that occupies \> 30% of the volume of the infarct and produces significant mass effect.

Countries

United States