Condition category
Cancer
Date applied
24/04/2013
Date assigned
25/04/2013
Last edited
26/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Miss Jenny Phillips

ORCID ID

Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
j.phillips@warwick.ac.uk

Type

Scientific

Additional contact

Ms Catherine Hill

ORCID ID

Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
catherine.hill@warwick.ac.uk

Type

Scientific

Additional contact

Prof Annie Young

ORCID ID

Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
annie.young@warwick.ac.uk

Additional identifiers

EudraCT number

2012-005589-37

ClinicalTrials.gov number

Protocol/serial number

14296

Study information

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

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

West Midlands – Coventry and Warwickshire, 08/02/2013, ref: 13/WM/0017

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Dalteparin (Fragmin®, Pfizer), Rivaroxaban (Xarelto®, Bayer)

Primary outcome measures

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 trial start date

01/05/2013

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

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) > 2x109/l, platelets > 100 x109/l).
6. Adequate hepatic and renal function – liver enzymes < x3 upper limit of normal (ULN) creatinine clearance > 30 ml per minute

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 530; UK Sample Size: 530

Participant 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

United Kingdom

Trial participating centre

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Industry

Funder name

Bayer PLC

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/05/2016: the overall trial end date was changed from 01/05/2015 to 31/12/2018.