SELECT-D: Anticoagulation therapy in SELECTeD cancer patients at risk of recurrence of venous thromboembolism
| ISRCTN | ISRCTN86712308 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86712308 |
| EudraCT/CTIS number | 2012-005589-37 |
| Secondary identifying numbers | 14296 |
- Submission date
- 24/04/2013
- Registration date
- 25/04/2013
- Last edited
- 30/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Miss Jaclyn Brown
Scientific
Scientific
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
| J.Brown.10@warwick.ac.uk |
Ms Catherine Hill
Scientific
Scientific
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
| select-d@warwick.ac.uk |
Prof Annie Young
Scientific
Scientific
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
| annie.young@warwick.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | SELECT-D: Anticoagulation therapy in SELECTeD cancer patients at risk of recurrence of venous thromboembolism: a prospective, randomised, open label, multicentre pilot study |
| Study acronym | SELECT-D |
| Study hypothesis | Prospective, randomised, open label, multicentre pilot study comparing dalteparin vs. rivoraxaban with a second placebo-controlled randomisation comparing the duration of anticoagulation therapy (6 months vs 12 months treatment) in Residual Vein Thrombosis [RVT] positive (+ve) patients. |
| Ethics approval(s) | West Midlands Coventry and Warwickshire, 08/02/2013, ref: 13/WM/0017 |
| Condition | Topic: National Cancer Research Network; Subtopic/Disease: All Cancers/Misc Sites |
| Intervention | Dalteparin (Fragmin®, Pfizer), A low molecular weight heparin, the only licensed anticoagulant in the UK for the extended treatment and prevention of recurrence of VTE in cancer patients. Rivaroxaban (Xarelto®, Bayer), An oral direct Factor Xa inhibitor, licensed for the treatment of DVT and the prevention of recurrence of DVT and PE in adult patients. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Dalteparin (Fragmin®, Pfizer), Rivaroxaban (Xarelto®, Bayer) |
| Primary outcome measure | VTE recurrence rates (including symptomatic VTE and incidental PE) calculated from the date of randomisation to the date of first VTE recurrence event. |
| Secondary outcome measures | 1. Acceptability of the study assessed by the numbers randomised and screening logs for reasons for non-randomisation 2. Biomarker correlation 3. Compliance to treatment assessed by the frequency of withdrawals of therapy and duration of therapy 4. Feasibility of conducting an economic evaluation 5. Major bleeding and clinically relevant non-major bleeding. Time to major bleed or clinically relevant non-major bleed calculated from date of randomisation 6. Overall survival; calculated from the date of randomisation to the date of death from any cause 7. Patient experience measured using Anti-Clot Treatment Scale (ACTS) 8. Progression-free survival (adjuvant patients) calculated from the date of randomisation to the date of first progression or death from any cause 9. Quality of life measured using the EuroQol EQ-5D-5L questionnaire 10. Symptomatic VTE and incidental PE recurrence rates calculated from the date of randomisation to the date of first recurrence event 11. Tumour efficacy measured using the Response Evaluation Criteria In Solid Tumors (RECIST) assessment |
| Overall study start date | 01/05/2013 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 530; UK Sample Size: 530. Final recruitment 406. |
| Participant inclusion criteria | 1. Patients with active cancer. 2. Patients with a primary presentation of an objectively confirmed venous thromboembolism (VTE) symptomatic deep venous thrombosis (DVT) or symptomatic or incidental pulmonary embolism (PE). 3. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2. 4. Age 18 years or over and written informed consent given. 5. Adequate haematological function (recommended levels haemoglobin (Hb) > 10g/dl, white cell count (WCC) > 2x10(9)/l, platelets > 100 x10(9)/l). 6. Adequate hepatic and renal function liver enzymes < x3 upper limit of normal (ULN) creatinine clearance > 30 ml per minute |
| Participant exclusion criteria | Current exclusion criteria as of 31/08/2018: 1. Primary oesophageal or gastro-oesophageal cancer 2. Patients taking any anticoagulants. 3. Patients on more than 75 mg aspirin per day. 4. More than 72 hours pre-treatment with anticoagulant for this episode. 5. Clinically significant liver disease (e.g. acute hepatitis, chronic active hepatitis, or cirrhosis) or an alanine aminotransferase level that is equal to or greater than 3 times ULN range. 6. Bacterial endocarditis. 7. Active bleeding or a high risk of bleeding, contraindicating anticoagulant treatment. 8. Systolic blood pressure greater than 180 mm Hg or Diastolic blood pressure greater than 110 mm Hg. 9. Of childbearing potential (both male and female participants) without a combination of proper contraceptive measures. 10. Pregnant or breastfeeding. 11. Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g. human immunodeficiency virus protease inhibitors or systemic ketoconazole) or inducers (e.g. rifampicin, carbamazepine, or phenytoin) and p-glycoprotein inhibitors/ inducers. Previous exclusion criteria: 1. Patients taking any anticoagulants. 2. Patients on more than 75 mg aspirin per day. 3. More than 72 hours pre-treatment with anticoagulant for this episode. 4. Clinically significant liver disease (e.g. acute hepatitis, chronic active hepatitis, or cirrhosis) or an alanine aminotransferase level that is equal to or greater than 3 times ULN range. 5. Bacterial endocarditis. 6. Active bleeding or a high risk of bleeding, contraindicating anticoagulant treatment. 7. Systolic blood pressure greater than 180 mm Hg or Diastolic blood pressure greater than 110 mm Hg. 8. Of childbearing potential (both male and female participants) without a combination of proper contraceptive measures. 9. Pregnant or breastfeeding. 10. Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g. human immunodeficiency virus protease inhibitors or systemic ketoconazole) or inducers (e.g. rifampicin, carbamazepine, or phenytoin) and p-glycoprotein inhibitors/ inducers. |
| Recruitment start date | 01/05/2013 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
Warwick Medical School
Coventry
CV4 7AL
England
United Kingdom
| Website | http://www2.warwick.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Industry
Bayer PLC
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 10/07/2018 | Yes | No | |
| Results article | results | 01/04/2020 | 30/01/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/01/2020: Publication reference added.
31/08/2018: The following changes have been made:
1. Jenny Phillips has been removed from the trial contacted and Jaclyn Brown added.
2. The participant exclusion criteria have been changed.
3. Publication reference added.
4. Final participant enrolment number added.
16/05/2016: the overall trial end date was changed from 01/05/2015 to 31/12/2018.
