biostudies-literatureSilver RMNational Institutes of HealthScleroderma Foundation403-411https://www.ebi.ac.uk/biostudies/studies/S-EPMC6858036biostudies-literatureUnknown1(7)<h4>Objective</h4>Interstitial lung disease (ILD) is a frequent complication of systemic sclerosis (SSc) (scleroderma) and the leading cause of scleroderma-related deaths. There exists an unmet need for a new drug therapy for ILD-complicated SSc. Substantial evidence supports an important role for thrombin in the pathogenesis of SSc-associated ILD (hereafter SSc-ILD), and targeting thrombin with a direct thrombin inhibitor could prove to be a novel and effective treatment strategy. As a first step toward designing a clinical trial to test the efficacy of thrombin inhibition in SSc-ILD, we conducted this study to test the safety and tolerability of dabigatran in patients with SSc-ILD.<h4>Methods</h4>We performed a prospective, single-center, open-label treatment trial with the direct thrombACR open rheumatologySafety and Tolerability of Thrombin Inhibition in Scleroderma-Associated Interstitial Lung Disease.PMC68580361 R21 AR065089‐01Huggins JTSilver RMAkter TKajdasz KBogatkevich GSAtanelishvili IHighland KBNietert PJWilson DAfalseSafety and Tolerability of Thrombin Inhibition in Scleroderma-Associated Interstitial Lung Disease.<h4>Objective</h4>Interstitial lung disease (ILD) is a frequent complication of systemic sclerosis (SSc) (scleroderma) and the leading cause of scleroderma-related deaths. There exists an unmet need for a new drug therapy for ILD-complicated SSc. Substantial evidence supports an important role for thrombin in the pathogenesis of SSc-associated ILD (hereafter SSc-ILD), and targeting thrombin with a direct thrombin inhibitor could prove to be a novel and effective treatment strategy. As a first step toward designing a clinical trial to test the efficacy of thrombin inhibition in SSc-ILD, we conducted this study to test the safety and tolerability of dabigatran in patients with SSc-ILD.<h4>Methods</h4>We performed a prospective, single-center, open-label treatment trial with the direct thromb2019-01-01T00:00:00Z2019 Sep2025-04-18T20:04:49.801Z2020-05-21T20:13:45ZS-EPMC68580363177782010.1002/acr2.11049