Clinical trial NCT06440044: Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism
Official title: Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis, Venous
Colo-rectal Cancer
Bleeding
Keywords: Venous Thrombembolism；Colorectal Cancer；Bleeding
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment at The Sixth Affiliated Hospital, Sun Yat-sen University from January 2019 to January 2023. VTE was considered cancer-related if the patient had a diagnosis of CRC within six months before or after the VTE diagnosis, any cancer treatment within the previous six months, or recurrent/metastatic cancer regardless of treatment.

Brief summary: Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Patients with CRC are underrepresented in the major trials examining treatment of cancer-associated VTE with anticoagulant.

Detailed description: Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Specifically, a subsequent analysis of the Hokusai study showed that the excess in MB was confined to patients with gastrointestinal cancer. In the RIETE registry, patients with gastrointestinal or genitourinary cancers experienced more bleeding outcomes while patients with brain or lung cancer experienced more thrombotic outcomes. However, in a subgroup analysis of the Caravaggio trial, major gastrointestinal bleeding in patients with CRC was low and similar in both apixaban and LMWH groups. Patients with CRC are underrepresented in the major trials examining treatment of CAT with anticoagulant. Despite concerns that DOACs pose a significant bleeding risk in CRC patients, many patients with CRC are treated with apixaban or rivaroxaban in clinical practice. Balancing risks of thrombosis recurrence and bleeding can be challenging and requires a nuanced, individualized approach to decision making to improve prognosis in this population. The aim of this study is to identify risk factors for recurrence and bleeding in CRC patients with VTE. Deaths, regardless of the mechanism, will also be included in the one year all-cause mortality outcome.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment.
2. CRC patients with VTE treated with an anticoagulant (rivaroxaban or LMWH) for at least six months.

Exclusion Criteria:

1. Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.

Primary outcomes:
measure: recurrent VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE)
timeFrame: From the date of index VTE to VTE recurrence, assessed up to 12 months
measure: Major Bleeding (MB)
timeFrame: From the date of index VTE to MB occurrence, assessed up to 12 months
measure: Clinical Relevant Non Major Bleeding (CRNMB)
timeFrame: From the date of index VTE to CRNMB occurrence, assessed up to 12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: One year follow up since index VTE identified until the date of death from any cause, whichever came first, , assessed up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: xiaoyan li
role: PRINCIPAL_INVESTIGATOR
References: