ePrints

Randomized, Multicenter Trial of ARTSS-2 (Argatroban with Recombinant Tissue Plasminogen Activator for Acute Stroke)

Lookup NU author(s): Professor Gary Ford

Downloads

Full text for this publication is not currently held within this repository. Alternative links are provided below where available.

Abstract

© 2017 American Heart Association, Inc. Background and Purpose-We conducted a randomized exploratory study to assess safety and the probability of a favorable outcome with adjunctive argatroban, a direct thrombin-inhibitor, administered to recombinant tissue-Type plasminogen activator (r-TPA)-Treated ischemic stroke patients. Methods-Patients treated with standard-dose r-TPA, not receiving endovascular therapy, were randomized to receive no argatroban or argatroban (100 μg/kg bolus) followed by infusion of either 1 (low dose) or 3 μg/kg per minute (high dose) for 48 hours. Safety was incidence of symptomatic intracerebral hemorrhage. Probability of clinical benefit (modified Rankin Scale score 0-1 at 90 days) was estimated using a conservative Bayesian Poisson model (neutral prior probability centered at relative risk, 1.0 and 95% prior intervals, 0.33-3.0). Results-Ninety patients were randomized: 29 to r-TPA alone, 30 to r-TPA+low-dose argatroban, and 31 to r-TPA+high-dose argatroban. Rates of symptomatic intracerebral hemorrhage were similar among control, low-dose, and high-dose arms: 3/29 (10%), 4/30 (13%), and 2/31 (7%), respectively. At 90 days, 6 (21%) r-TPA alone, 9 (30%) low-dose, and 10 (32%) high-dose patients were with modified Rankin Scale score 0 to 1. The relative risks (95% credible interval) for modified Rankin Scale score 0 to 1 with low, high, and either low or high dose argatroban were 1.17 (0.57-2.37), 1.27 (0.63-2.53), and 1.34 (0.68-2.76), respectively. The probability that adjunctive argatroban was superior to r-TPA alone was 67%, 74%, and 79% for low, high, and low or high dose, respectively. Conclusions-In patients treated with r-TPA, adjunctive argatroban was not associated with increased risk of symptomatic intracerebral hemorrhage and provides evidence that a definitive effectiveness trial is indicated. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01464788.

Publication metadata

Author(s): Barreto AD, Ford GA, Shen L, Pedroza C, Tyson J, Cai C, Rahbar MH, Grotta JC

Publication type: Article

Publication status: Published

Journal: Stroke

Year: 2017

Volume: 48

Issue: 6

Pages: 1608-1616

Print publication date: 01/06/2017

Online publication date: 15/05/2017

Acceptance date: 17/03/2017

ISSN (print): 0039-2499

ISSN (electronic): 1524-4628

Publisher: Lippincott Williams and Wilkins

URL: https://doi.org/10.1161/STROKEAHA.117.016720

DOI: 10.1161/STROKEAHA.117.016720

Altmetrics

Share