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NCT Number: NCT04846556

Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO

Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.

Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.

However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.

Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.

The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.

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Key information

Conditions

Venous Thromboembolism Cancer Cardiovascular Diseases Embolism and Thrombosis Neoplasms Thromboembolism Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens, Amiens, France

Loading trial locations.

About this study

The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consecutive patients with a newly diagnosed, objectively confirmed:

  • symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
  • symptomatic or unsuspected Pulmonary Embolism (PE)

Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:

  • Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
  • Cancer diagnosed within 2 years.

Exclusion criteria

  • pregnant women or breast feeding

Treatment and study plan

Data Collection

Other

data collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE).

Primary outcomes

  1. Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study

    Time frame: Up to 6 months after venous thromboembolic event

    Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) :

    • ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV;
    • life expectancy of less than 6 months;
    • 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;
    • thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
    • recent brain, spinal or ophthalmic surgery
    • hemoglobin level lower than 8 g/dL or platelet count <75x10^9/L or history of heparin induced thrombocytopenia;
    • creatinine clearance < 30 ml /min
    • acute hepatitis, chronic active hepatitis, liver cirrhosis;
    • uncontrolled hypertension;
    • concomitant use of strong inhibitors or inducers of cytochrome;
    • bacterial endocarditis;

Secondary outcomes

  1. Drugs used for their VTE

    Time frame: Up to 6 months after venous thromboembolic event

    Collected in medical history.

  2. Confirmed recurrent Venous Thromboembolic Event (VTE)

    Time frame: Up to 6 months after venous thromboembolic event

    Collected in medical history.

    • Pulmonary embolism
    • deep venous thrombosis

  3. Bleeding event

    Time frame: Up to 6 months after venous thromboembolic event

    Collected in medical history.

  4. Death

    Time frame: Up to 6 months after venous thromboembolic event

    Collected in medical history.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2021
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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