FindTrial
Sign In

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03045406
Acronym
CARAVAGGIO
Enrollment
1170
Registered
2017-02-07
Start date
2017-04-13
Completion date
2019-12-01
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Brief summary

Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

Interventions

DRUGApixaban

Tablets

DRUGDalteparin

Injections

Sponsors

University Of Perugia
CollaboratorOTHER
Fadoi Foundation, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery; * Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia); * Signed and dated informed consent of the patient, available before the start of any specific trial procedure.

Exclusion criteria

* age \<18 years; * ECOG Performance Status III or IV; * life expectancy of less than 6 months; Related to anticoagulant treatment: * administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; * 3 or more doses of a vitamin K antagonist before randomization; * thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; * indication for anticoagulant treatment for a disease other than the index VTE episode; Related to bleeding risk: * thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; * active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; * recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery * hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count \<75x10\^9/L or history of heparin induced thrombocytopenia; * creatinine clearance \< 30 ml /min based on the Cockcroft Gault equation; * acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range; * uncontrolled hypertension (systolic BP\> 180 mmHg or diastolic BP \> 100 mmHg despite antihypertensive treatment); * concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein; Standard criteria: * bacterial endocarditis; * hypersensitivity to the active substance or to any of the excipients of study drug; * patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system; * childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; * any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.

Design outcomes

Primary

MeasureTime frameDescription
Recurrent Venous Thromboembolism6 monthsPrimary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of: · proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected)

Countries

Belgium, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States

Participant flow

Participants by arm

ArmCount
Apixaban
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months) Apixaban: Tablets
576
Dalteparin
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months Dalteparin: Injections
579
Total1,155

Baseline characteristics

CharacteristicApixabanTotalDalteparin
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
377 Participants746 Participants369 Participants
Age, Categorical
Between 18 and 65 years
199 Participants409 Participants210 Participants
Age, Continuous67.2 years
STANDARD_DEVIATION 11.3
67.2 years
STANDARD_DEVIATION 11.1
67.2 years
STANDARD_DEVIATION 10.9
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants5 Participants2 Participants
Race (NIH/OMB)
Black or African American
9 Participants18 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
107 Participants206 Participants99 Participants
Race (NIH/OMB)
White
456 Participants925 Participants469 Participants
Region of Enrollment
Belgium
2 participants9 participants7 participants
Region of Enrollment
France
102 participants192 participants90 participants
Region of Enrollment
Germany
14 participants28 participants14 participants
Region of Enrollment
Israel
18 participants26 participants8 participants
Region of Enrollment
Italy
204 participants397 participants193 participants
Region of Enrollment
Netherlands
64 participants138 participants74 participants
Region of Enrollment
Poland
10 participants20 participants10 participants
Region of Enrollment
Portugal
8 participants13 participants5 participants
Region of Enrollment
Spain
80 participants175 participants95 participants
Region of Enrollment
United Kingdom
14 participants32 participants18 participants
Region of Enrollment
United States
60 participants125 participants65 participants
Sex: Female, Male
Female
284 Participants587 Participants303 Participants
Sex: Female, Male
Male
292 Participants568 Participants276 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
135 / 576153 / 579
other
Total, other adverse events
89 / 57674 / 579
serious
Total, serious adverse events
255 / 576276 / 579

Outcome results

Primary

Recurrent Venous Thromboembolism

Primary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of: · proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected)

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ApixabanRecurrent Venous Thromboembolism32 Participants
DalteparinRecurrent Venous Thromboembolism46 Participants

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026