Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment
About this study
The aim of this trial is to find out if a tablet called apixaban can reduce blood clots in people with lung cancer having chemotherapy or similar treatments. Apixaban is a type of oral anticoagulant ("blood thinner") that makes the blood less sticky to prevent blood clots forming. The trial is trying to find out if apixaban it can reduce blood clots in people with lung cancer. Participants will receive the following treatment: • Apixaban or placebo, 2.5mg taken by mouth twice a day for 6 months. This treatment will be taken in addition to any treatment that they are receiving to treat their lung cancer. Participants will need to: * Sign a consent form to enter the trial. * Take the trial treatment as directed by the research team * Complete a participant diary to record when they took the trial treatment * Complete the Quality of Life and Health resource use questionnaires. * Female participants of childbearing potential must use adequate contraception during the trial and for at least 2 days after trial treatment has finished.
- Condition
- Thromboprophylaxis
- Tested
- Apixaban, Placebo
- Sponsor
- University of Birmingham
Who can join
- Age
- 16 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 16 years
- Study condition: Thromboprophylaxis
- Age ≥ 16 years
- Newly diagnosed locally advanced or metastatic primary lung cancer (histologically/ cytologically confirmed) or disease progression after complete or partial remission commencing a new course of SACT alone or as CRT
- Ambulatory (receiving outpatient SACT)
Exclusion 17
- Hypersensitivity to apixaban or to any of the listed SmPC excipients
- Active clinically significant bleeding
- Lesion or condition considered a significant risk factor for major bleeding
- Hepatic disease associated with impaired synthetic function
- Platelet count \< 50 x 109 /L
- Elevated liver enzymes ALT/AST \> 2 x ULN or total bilirubin ≥ 1.5 x ULN
- Renal failure (creatinine clearance \< 15ml/min)
- Weight \< 40kg
- Estimated life expectancy \< 6 months
- Continuous anticoagulation (e.g., unfractionated heparin, low molecular weight heparins, heparin derivatives and oral anticoagulants) for other medical conditions
- The usage of medications contraindicated with apixaban
- Pregnancy
- Breast feeding
- Judgement by the Investigator that the participant is unsuitable to participate in the trial and the participant is unlikely to comply with trial procedures, restrictions and requirements
- Inability to consent
- Receiving SACT for potentially resectable / resectable lung cancer as part of neo-adjuvant or adjuvant treatment
- SACT with significant potential DDI with apixaban (section 7.2.3)
Where
8 sites, 8 recruiting
Dorset County Hospital
Dorchester, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
James Paget Hospital
Gorleston-on-Sea, United Kingdom
Withybush General Hospital
Haverfordwest, United Kingdom
Queen Elizabeth Hospital
London, United Kingdom
Queens Hospital Romford
Romford, United Kingdom
and 2 more sites on ClinicalTrials.gov
Contact
-
Ann Pope, PhD
+44 4146372 THROMBO-STOP@trials.bham.ac.uk
-
Sophia Magwaro, BSc
Potential match only. Final eligibility is determined by the study team.