====== Novel oral anticoagulants ====== [[Novel oral anticoagulant]]s (NOAs) which directly inhibit thrombin ([[dabigatran]]) or [[factor Xa]] ([[rivaroxaban]] and [[apixaban]]) have recently been developed. ---- Compared to [[vitamin K antagonist]]s (VKAs) (e.g. [[warfarin]]), the novel [[oral anticoagulant]]s (NOACs) [[dabigatran]], [[rivaroxaban]] & [[edoxaban]] are at least as effective in preventing [[ischemic stroke]] and systemic embolization in a patient with [[atrial fibrillation]]. And compared to warfarin, NOACs reduce [[ICH]] by about 50%, ((Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomized trials. Lancet. 2014; 383:955–962)) have a more rapid onset of action, a shorter half-life, more predictable pharmacokinetics, fewer drug-drug interactions, and do not require routine monitoring ((Bernhardt J, Zorowitz RD, Becker KJ, et al. Advances in Stroke 2017. Stroke. 2018; 49:e174–e199)). ---- The purpose of a study was the evaluation of the reporting quality of [[RCT]]s for [[novel oral anticoagulant]]s (NOACs) in [[venous thromboembolism]] (VTE) based on the [[CONSORT]] statement. [[MEDLINE]] was meticulously searched, while quoted [[reference]]s by retrieved RCTs were manually screened. The primary objective was to establish the mean CONSORT compliance of RCTs for NOACs in VTE. Secondary objectives were the calculation of compliance per CONSORT item and the investigation for probable determining factors with regards to the reporting quality of RCTs. Reporting above 70% of the items was defined as adequate compliance to the CONSORT statement. A total of 83 articles were considered eligible. Mean adherence to the CONSORT statement was 61.84%, standard deviation (SD) = 18.72. Among retrieved studies, 35 (42.17%) reported above 70% of the items, while 48 (57.83%) described less than 70% of the items. Inter-rater agreement was satisfactory (Cohen's kappa ≥ 0.75). Items with respect to randomization and blinding were principally underreported, whereas the rest of the methodological features and results were more sufficiently reported. Logistic regression failed to demonstrate significant effect for any of the factors investigated. Impact factor [odds ratio (OR) = 1.347, 95% confidence interval (CI) (0.994, 1.826), p = 0.055], number of authors [OR = 1.277, 95% CI (0.975, 1.672), p = 0.076] and presentation of participant flow-diagram [OR = 55.358, 95% CI (0.914, 3351.765), p = 0.055], came closer to significance. Exploratory analysis revealed significant, strong, positive correlation between abstract and article adherence to the CONSORT guidelines (r = 0.851, p < 0.001). Reporting quality of RCTs for NOACs in VTE is moderate. A superior reporting quality is desirable, especially relating to [[randomization]] and [[blinding]] ((Liampas I, Chlinos A, Siokas V, Brotis A, Dardiotis E. Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement. J Thromb Thrombolysis. 2019 Aug 10. doi: 10.1007/s11239-019-01931-9. [Epub ahead of print] Review. PubMed PMID: 31401718. )). ===== Apixaban ===== [[Apixaban]] ===== References =====