select-d: Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism
select-d: Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism
Main objective of the trial
To assess whether rivaroxaban is any better than dalteparin for the treatment of venous thromboembolism in cancer patients.
Secondary objectives of the trial
The secondary objectives are as follows:
• To assess 6 months and 12 months treatment with rivaroxaban in patients with evidence of residual vein thrombosis (RVT), following initial therapy in terms of VTE recurrence rates.
• To assess the VTE recurrence rates in patients with evidence of residual vein thrombosis (RVT) and those with no evidence of RVT.
• To assess acceptability and compliance to randomisation and allocated treatment.
• To ensure the safety of the patients with regards to major bleeding in an internal safety study.
Primary end point(s)
The primary outcome is the VTE recurrence rates (including symptomatic VTE and incidental PE) for dalteparin and rivaroxaban.
EudraCT Number: 2012-005589-37
Sponsor's Protocol Code Number: RMRHS0095
National Competent Authority: UK - MHRA
Enrollment: 530
Trial Status: Completed
Start Date: 2013-03-08
Date of the global end of the trial: 2019-07-31
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 530 |
| Study start date | 08 March 2013 |
| Actual study completion date | 31 July 2019 |