Randomized, Multicenter Trial of ARTSS-2 (Argatroban With Recombinant Tissue Plasminogen Activator for Acute Stroke)
| Autor: | Andrew D. Barreto, Gary A. Ford, Loren Shen, Claudia Pedroza, Jon Tyson, Chunyan Cai, Mohammad H. Rahbar, James C. Grotta, Zahra Ajani, Andrei V. Alexandrov, Igor Cherches, Bruce Coull, Jesse Dawson, Debra del Junco, Andrew Demchuk, Joseph Devine, Aisha S. Dickerson, Anand Dixit, James L. Frey, Martin James, Usman Khan, Steven Levine, Claire MacDonald, Marc Malkoff, Elaine McColl, Vivek Misra, Michael Mullen, Richard Perry, Bartlomiej Piechowski-Jozwiak, Christine Roffe, Navi Sangha, April Sisson, Georgios Tsivgoulis, John J. Volpi |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment 030204 cardiovascular system & hematology Tissue plasminogen activator Argatroban law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Multicenter trial Internal medicine Severity of illness medicine Stroke Advanced and Specialized Nursing business.industry Thrombolysis medicine.disease Anesthesia Neurology (clinical) Cardiology and Cardiovascular Medicine business 030217 neurology & neurosurgery Fibrinolytic agent medicine.drug |
| Zdroj: | Stroke. 48:1608-1616 |
| ISSN: | 1524-4628 0039-2499 |
| DOI: | 10.1161/strokeaha.117.016720 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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