Treatment of thrombosis in the veins with apixaban

• Register: EUCTR
• Last refreshed on: 29 August 2016
• Main ID: EUCTR2014-005439-15-NO
• Date of registration: 23/10/2015
• Prospective Registration: Yes
• Primary sponsor: Akershus University Hospital
• Public title: Treatment of thrombosis in the veins with apixaban
• Scientific title: Apixaban for treatment of venous thrombosis in patients with cancer. - The CAP study
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005439-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Norway

Contacts

• Name: The CAP study nurse
• Affiliation: Akershus university hospital

• Name: The CAP study nurse
• Affiliation: Akershus university hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Age > 18 years
A diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer.
Objectively verified VT
Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion criteria:
Anticoagulant therapy prior to trial entry for > 96 hours
Severe thrombocytopenia (platelets <50•109/L)
Severe renal failure – creatinine clearance <30 ml/min
The patients will be treated with catheter based thrombolysis for DVT or systemic thrombolysis for severe pulmonary embolism
Pregnancy or breastfeeding.
Childbearing potential without proper contraceptive measures
Drug abuse or mental disease that may interfere with treatment and follow-up.
Severe malabsorption so that oral treatment are expected to have reduced effect
Mechanical heart valves
Active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the VT
Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis)
Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, vorikonazol or posakonazol) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Venous thrombosis in patients with cancer

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Eliquis
Pharmaceutical Form: Coated tablet

Primary Outcome(s)

Main Objective: To evaluate if apixaban is safe in the treatment of VT in cancer patients.
To evaluate if apixaban is effective in the treatment of VT in cancer patients.

Primary end point(s): Primary endpoint of safety: Rate of major or clinically relevant non-major bleeding after 6 months.
Primary endpoint of efficacy: Rate of recurrent objectively confirmed VT or death related to VT within 6 months.

Secondary Objective: To evaluate if apixaban influence mortality in cancer patients with VT.
To identify risk factors for bleeding and recurrent VT in patients with VT and cancer.

Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome(s)

Secondary end point(s): All cause mortality after 6 months
All cause mortality after 24 months
Rate of recurrent VT after 24 months
Rate of major or clinically relevant non-major bleeding after 24 months

Timepoint(s) of evaluation of this end point: 6 and 24 months

Secondary ID(s)

CAP

Source(s) of Monetary Support

Akershus university hospital

Norwegian research council