6/29/23, 1:44 AM PROTECHT Pathway Feedback Search Clinical Topics Home Studies PROTECHT PROTECHT Disease Cancer-associated thrombosis Trial question What is the role of nadroparin in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy? Study design Multi-center Double blinded RCT Population Characteristics of study participants 52.0% female N = 1150 48.0% male 1150 patients (595 female, 555 male) Inclusion criteria: ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer Key exclusion criteria: adjuvant or neoadjuvant chemotherapy; venous or arterial thromboembolism in < 3 months; ECOG score > 2; antithrombotic treatment for any indication; life expectancy < 3 months; active bleeding Interventions N=769 nadroparin (3800 IUs anti-Xa once daily) N=381 placebo (matching placebo once daily) https://web.pathway.md/studies/recFc7qawvkMpVWKE 1/2 6/29/23, 1:44 AM PROTECHT Pathway Primary outcome Symptomatic venous or arterial thromboembolic events 3.9 % 3.9 2.9 % 2 1.9 % Significant decrease 1.0 % NNT = 53 0.0 % Nadroparin Placebo Significant decrease in symptomatic venous or arterial thromboembolic events (2% vs. 3.9%; RR 0.51, 95% CI 0.08 to 0.94) Safety outcomes No significant difference in major bleeding and serious adverse events. Conclusion In ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer, nadroparin was superior to placebo with respect to symptomatic venous or arterial thromboembolic events. Reference Giancarlo Agnelli, Gualberto Gussoni, Carlo Bianchini et al. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study. Lancet Oncol. 2009 Oct;10(10):943-9. Open reference URL https://web.pathway.md/studies/recFc7qawvkMpVWKE 2/2