PROTECHT
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
48.0% male
N = 1150
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).
Primary outcome
Symptomatic venous or arterial thromboembolic events
2%
3.9%
3.9 %
2.9 %
1.9 %
1.0 %
0.0 %
Nadroparin
Placebo
Significant
decrease ▼
NNT = 52
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.
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