THROMBO-STOP
Research type
Research Study
Full title
A phase III, multicentre, double blind, placebo-controlled, randomised clinical trial of apixaban thromboprophylaxis to prevent venous thromboembolism in ambulatory lung cancer patients undergoing systemic anticancer treatment
IRAS ID
1012637
Contact name
Becky Case
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
Research summary
Lung cancer affects about 50,000 people every year in the UK, and around 11,000 of them get medicines called systemic anticancer therapy (SACT) to treat it. SACT includes treatments like chemotherapy, immunotherapy, or targeted therapy, which help fight the cancer. A common complication of lung cancer, and its treatment, can be blood clots known medically as venous thromboembolism (VTE). These clots most commonly occur in the legs (known as Deep Vein Thrombosis or DVT) or in the lungs (Pulmonary Emboli or PE). The blood clots can make current symptoms worse, decrease quality of life and in some cases be fatal. They have been found to happen 7 times more often in patients with lung cancer than in members of the general population. Because lung cancer is common and a major cause of death in the UK, it is important to try and prevent these blood clots occurring.
Doctors can use medicines called anticoagulants, also known as "blood thinners," to make the blood less sticky and prevent it from forming blood clots. Most of the information we currently have about preventing blood clots in lung cancer is for the injection types of anticoagulants. There are now newer forms of tablet treatment called direct oral anticoagulants (DOACs) that are easier to take and don’t require regular checks. DOACs are widely used in the UK for several conditions but more information is needed about if they can prevent blood clots in lung cancer. Patients with lung cancer who are being given SACT do not currently receive treatment with anticoagulants to prevent VTE. This study wants to find out if DOACs can help prevent blood clots in lung cancer patients getting SACT. It will focus on patients with lung cancer who are being treated as out patients. We will enrol 1,456 people from different UK hospitals. Half will get the DOACs, and half will get a placebo (dummy pill) for 6 months. Patients will be followed up to see if the oral DOAC medicines make a difference by reducing blood clots.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0242
Date of REC Opinion
3 Dec 2025
REC opinion
Further Information Favourable Opinion