SELECT-D: Anticoagulation therapy in SELECTeD cancer patients at risk of recurrence of venous thromboembolism

ISRCTN	ISRCTN86712308
DOI	https://doi.org/10.1186/ISRCTN86712308
Clinical Trials Information System (CTIS)	2012-005589-37
Protocol serial number	14296
Sponsor	University of Warwick (UK)
Funder	Bayer PLC

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 of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-comparing-blood-thinning-injection-with-blood-thinning-tablet-for-people-with-cancer-who-have-blood-clot-select-d

Contact information

Miss Jaclyn Brown
Scientific

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email	J.Brown.10@warwick.ac.uk

Ms Catherine Hill
Scientific

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email	select-d@warwick.ac.uk

Prof Annie Young
Scientific

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email	annie.young@warwick.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Dalteparin (Fragmin®, Pfizer), Rivaroxaban (Xarelto®, Bayer)
Primary outcome measure(s)	VTE recurrence rates (including symptomatic VTE and incidental PE) calculated from the date of randomisation to the date of first VTE recurrence event.
Key secondary outcome measure(s)	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
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	530
Key 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
Key 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.
Date of first enrolment	01/05/2013
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Warwick Medical School

Coventry
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2020	30/01/2020	Yes	No
HRA research summary			28/06/2023	No	No
Interim results article	interim results	10/07/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.