Long-term outcome after heparin plus edoxaban versus heparin plus vitamin K antagonists for acute deep vein thrombosis and pulmonary embolism

Long-term outcome after heparin plus edoxaban versus heparin plus vitamin K antagonists for acute deep vein thrombosis and pulmonary embolism - Hokusai post VTE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42861

Enrollment

255

Registered

2016-10-28

Start date

2017-04-25

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

kwaliteit van leven embolism thrombosis

Interventions

DOAC

Post thrombotic syndrome

Quality of Life

Vitamin K antagonist

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients from centers that participated in the Hokusai VTE trial and where implementation of this study is feasible.

Exclusion criteria

Exclusion criteria: Inability for follow-up due to geographic or logistic reasons, or death.

Design outcomes

Primary

Measure	Time frame
The primary outcome among the DVT group is the cumulative incidence of PTS in patients with an acute DVT treated with heparin plus edoxaban versus heparin plus warfarin. PTS is defined as a Villalta total score of >=5 or the presence of a venous ulcer. Among the PE patients, the primary outcomes are Quality of Life (SF-36 and PembQoL) at least 2 years after the index PE.	—

Secondary

Measure	Time frame
Secondary study outcomes are the QOL of patients with PTS compared to patients without PTS and the incidence of PTS based on the patient-reported Villalta compared to the original Villalta scale score. Among the PE patients, the secondary study outcome is the feasibility of pro-active case-finding of CTEPH in Hokusai post VTE study selected patients with acute PE by use of a recently derived risk stratification score based on clinical variables and detailed assessment of index CTPA scans.	—

Measure

Time frame

Secondary study outcomes are the QOL of patients with PTS compared to patients without PTS and the incidence of PTS based on the patient-reported Villalta compared to the original Villalta scale score. Among the PE patients, the secondary study outcome is the feasibility of pro-active case-finding of CTEPH in Hokusai post VTE study selected patients with acute PE by use of a recently derived risk stratification score based on clinical variables and detailed assessment of index CTPA scans.

—

Countries

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, New Zealand, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)