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

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic/Disease: All Cancers/Misc Sites; Cancer; Malignant neoplasm, unspecified

• Registration Number: ISRCTN86712308
• Lead Sponsor: niversity of Warwick (UK)

Brief Summary

2018 interim results in https://www.ncbi.nlm.nih.gov/pubmed/29746227 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31995662 (added 30/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-25
• Study Completion: 2018-12-31
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 530

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VTE recurrence rates (including symptomatic VTE and incidental PE) calculated from the date of randomisation to the date of first VTE recurrence event.