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

NCT03895502 | Completed Phase 4 DMC

• 1 other identifier: Y0019
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thrombosis; Neoplasms; Anticoagulant

Keywords

Venous Thrombosis; Neoplasms; Anticoagulant

Outcome Measures

Primary Outcomes (1)

• Symptomatic VTE recurrence event or VTE related death event

  Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. VTE related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer.)

  12 months

Secondary Outcomes (11)

• Major bleeding event (ISTH criteria)

  12 months

• All-cause death

  12 months

• Symptomatic VTE recurrence event

  12 months

• VTE related death event

  12 months

• Clinically relevant non-major (CRNM) bleeding

  12 months

Study Arms (2)

12-month Edoxaban

EXPERIMENTAL

Edoxaban for 12 months

Drug: 12-month Edoxaban

3-month Edoxaban

ACTIVE COMPARATOR

Edoxaban for 3 months

Drug: 3-month Edoxaban

Interventions

12-month Edoxaban DRUG

Prescription of Edoxaban for 12 months

12-month Edoxaban

3-month Edoxaban DRUG

Prescription of Edoxaban for 3 months

3-month Edoxaban

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeshi Morimoto: lead

Study Sites (1)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Kyoto, 606-8507, Japan

Location

Related Publications (3)

• 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.

  PMID: 40766276 DERIVED

• 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.

  PMID: 38650055 DERIVED

• 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.

  PMID: 37638968 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Neoplasms

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Takeshi Kimura, MD, PhD

  Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: May 27, 2019
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

JP (1)