select-d: Anticoagulation therapy in SELECTeD cancer patients at risk of re... | Not Recruiting
select-d: Anticoagulation therapy i... | Not Recruiting
select-d: Anticoagulation therapy in SELECTeD cancer patients at risk of recurrence of venous thromboembolism
select-d

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic/Disease: All Cancers/Misc Sites
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN86712308
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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
Research Details
  • 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.
Phase
Phase III
Study Design
Randomised; Interventional; Design type: Treatment
Study Type
Interventional
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
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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 530; UK Sample Size: 530
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 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.
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Coventry
CV4 7AL
Trial Contact(s)
Primary Trial Contact
Miss Jenny Phillips
-
Other Trial Contacts
Ms Catherine Hill
-
Prof Annie Young
-
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
2012-005589-37
Funder(s)
  • Bayer PLC
Other Study ID Numbers
14296
Sponsor(s)
University of Warwick (UK)
Key Dates

Recruitment Start Date

01 May 2013

Recruitment End Date

31 Dec 2016

Trial Start Date

01 May 2013

Trial End Date

31 Dec 2018

Date added to source

25 Apr 2013

Date updated in source

26 May 2016