Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study

NCT ID: NCT03895502

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2023-08-31

Brief Summary

The purpose of this study is to determine the optimal duration of anticoagulation therapy (3 months versus 12 months) with direct oral anticoagulant (edoxaban) for isolated distal deep vein thrombosis.

Detailed Description

Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating PE and/or proximal DVT, although data on isolated distal DVT (IDDVT) has been quite limited. However, IDDVT was reported to account for about half of all the diagnoses of DVT detected on ultrasound in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines suggest the same approach for IDDVT patients with cancer as proximal DVT patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that IDDVT patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, we will randomly assign IDDVT patients with active cancer to receive either edoxaban for 3 months (short DOAC group) or edoxaban for 12 months (long DOAC group).

Conditions

Venous Thrombosis; Neoplasms; Anticoagulant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

12-month Edoxaban

Edoxaban for 12 months

Group Type: EXPERIMENTAL

12-month Edoxaban

Intervention Type: DRUG

Prescription of Edoxaban for 12 months

3-month Edoxaban

Edoxaban for 3 months

Group Type: ACTIVE_COMPARATOR

3-month Edoxaban

Intervention Type: DRUG

Prescription of Edoxaban for 3 months

Interventions

12-month Edoxaban

Prescription of Edoxaban for 12 months

Intervention Type: DRUG

3-month Edoxaban

Prescription of Edoxaban for 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with newly found isolated distal deep vein thrombosis
• Patients complicated with active cancer
• Patients who are scheduled to be treated by anticoagulation therapy.

Exclusion Criteria

• Patients with anticoagulation therapy for the index event before 10 days of allocation.
• Patient under anticoagulation therapy for the purpose of other than the index event.
• Patients with thrombolysis therapy or IVC filter at the Index event.
• Patients with creatinine clearance less than 30 ml/min.
• Patients who are expected to have a life prognosis of 3 months or less.
• Patients with pulmonary embolism.
• Patients who are not appropriate for the participation of the study.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeshi Morimoto

OTHER

Sponsor Role: lead

Responsible Party

Takeshi Morimoto

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Takeshi Kimura, MD, PhD

Role: STUDY_CHAIR

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Locations

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Kyoto, , Japan

Countries

Japan

References

Nishikawa T, Yamashita Y, Fujita M, Morimoto T, Muraoka N, Umetsu M, Nishimoto Y, Takada T, Ogihara Y, Ikeda N, Otsui K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Chatani R, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Yasui T, Yamamoto H, Ono K, Kimura T; ONCO DVT Study Investigators. D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis. Blood Vessel Thromb Hemost. 2025 Feb 24;2(2):100063. doi: 10.1016/j.bvth.2025.100063. eCollection 2025 May.

Reference Type: DERIVED

PMID: 40766276 (View on PubMed)

Chatani R, Yamashita Y, Morimoto T, Muraoka N, Umetsu M, Nishimoto Y, Takada T, Ogihara Y, Nishikawa T, Ikeda N, Otsui K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Mushiake K, Kadota K, Ono K, Kimura T. Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study. Eur Heart J Cardiovasc Pharmacother. 2024 Aug 14;10(5):422-431. doi: 10.1093/ehjcvp/pvae028.

Reference Type: DERIVED

PMID: 38650055 (View on PubMed)

Yamashita Y, Morimoto T, Muraoka N, Oyakawa T, Umetsu M, Akamatsu D, Nishimoto Y, Sato Y, Takada T, Jujo K, Minami Y, Ogihara Y, Dohi K, Fujita M, Nishikawa T, Ikeda N, Hashimoto G, Otsui K, Mori K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Chatani R, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Mo M, Yoshikawa Y, Kimura T; ONCO DVT Study Investigators. Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis (ONCO DVT Study): An Open-Label, Multicenter, Randomized Clinical Trial. Circulation. 2023 Nov 21;148(21):1665-1676. doi: 10.1161/CIRCULATIONAHA.123.066360. Epub 2023 Aug 28.

Reference Type: DERIVED

PMID: 37638968 (View on PubMed)

Other Identifiers

Y0019

Identifier Type: -

Identifier Source: org_study_id