API-CAT
Research type
Research Study
Full title
Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
IRAS ID
264398
Contact name
Anthony Maraveyas
Contact email
Sponsor organisation
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eudract number
2017-003342-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 11 days
Research summary
Patients who have had a clot (in the lung - a pulmonary embolism or in the leg - a DVT) during their treatment for cancer are usually treated with a course of blood thinners for about 6 months. This is the current standard practice. However, we know that cancer treatments and the cancer condition itself may last for longer than this. Therefore, the risks of a clot happening again remain. We do not know if prolonging anti-coagulation treatment at the full dose reduces these risks while keeping the risk of bleeding acceptable. There is evidence from the non-cancer patient that a reduced dose of the blood thinner after 6 months of full dose treatment can protect the patient equally as well as the higher dose and reduce the risk of bleeding. We do not know if this is true in patients who have had a clot and who also have cancer.
The objective of this study is to evaluate treatment with a blood thinner in cancer patients who have been receiving at least 6 months of the treatment for a clot by giving them a further 6 months of either a full dose of the blood thinner (5mg Apixaban twice per day) or a half dose (2.5mg Apixaban twice per day). The treatment will be randomly assigned to patients (randomisation). Since the tablets of the different doses do not have the same appearance (different size), the treatment will be made up with a placebo so neither the patient nor the investigator know which group the patient belongs to (double blind). However, both groups will get blood thinner.
The study is an international study which plans to include 1700 patients with cancer being treated for a clot at 160 European hospitals. We will be collecting data on the recurrence of a clot and the bleeding events.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0795
Date of REC Opinion
10 Jul 2019
REC opinion
Further Information Favourable Opinion