Anticoagulation therapy in selected cancer patients at risk of recurrence of venous thromboembolism

Conditions: Venous Thromboembolism and Cancer
MedDRA version: 14.1Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864
MedDRA version: 14.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005589-37-GB

Lead Sponsor: niversity of Warwick

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 530

Inclusion Criteria

1. Patients with active cancer. 2. Patients with a primary presentation of an objectively confirmed VTE - symptomatic DVT or symptomatic or incidental PE. 3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

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 breast-feeding. 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.