NCT05229471: REDUCE

Management of Recurrent Venous Thromboembolism During Anticoagulant Treatment in Cancer Patients - a Prospective Cohort Study

Status unknown Last updated 27 July 2023

What this trial tests

trial in Cancer in 220 participants. Status unknown.

Timeline

2 June 2020

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	220
Start date	2 June 2020
Primary completion	31 December 2023
Estimated completion	31 December 2024
Sites	9 locations across Italy, Netherlands, Spain

Conditions studied

• Cancer — all drugs for Cancer →
• Venous Thromboembolism — all drugs for Venous Thromboembolism →
• Recurrence — all drugs for Recurrence →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Adults 18 to 120, any sex, with Cancer or Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: To prospectively evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis.

Study design: International, prospective, observational cohort study Study population: Adult cancer patients with symptomatic or incidental recurrent VTE while receiving LMWH or DOACs for acute VTE are eligible. Main exclusion criteria include anticoagulant treatment for the recurrent VTE for more than 72 hours, severe hepatic dysfunction, active bleeding, recent major surgery, uncontrolled hypertension, known bleeding diathesis, and a life expectancy of less than 1 month.

Study procedures: Patients will be managed at the discretion of the treating physician, who will be encouraged to follow guideline recommendations. These guidelines suggest supra-therapeutic dose LMWH for 4 weeks (+/- 5 days) followed by therapeutic dose LMWH or therapeutic dose DOAC, while it is suggested to treat patients with VTE recurrence during maintenance dose LMWH (i.e. 75 to 80% of full therapeutic weight adjusted dose) with therapeutic dose of LMWH or DOAC.

Main study parameters/endpoints: The co-primary outcomes are new symptomatic or incidental recurrent VTE during 3 months of follow-up and on-treatment major bleeding. Secondary outcomes include recurrent incidental VTE, recurrent symptomatic VTE, recurrent incidental or symptomatic proximal or distal DVT, recurrent incidental or symptomatic PE, clinically relevant non-major bleeding, all-cause mortality, and cancer-related mortality. VTE occurring at other sites such as cerebral DVT or splanchnic DVT will also be recorded.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Occurrence and management of thrombosis recurrence and bleeding in low-molecular-weight heparin-treated patients with cancer-associated thrombosis: a French nationwide cohort study.
   Mahé I, Gusto G, Quignot N, Khachatryan A, et al · · 2025 · cited 2× · PMID 39868402 · DOI 10.1016/j.rpth.2024.102642
2. Management of Cancer-Associated Thrombosis in France: A National Survey among Vascular Disease and Supportive Care Specialists.
   Mahé I, Chapelle C, Plaisance L, Bertoletti L, et al · · 2022 · cited 1× · PMID 36077680 · DOI 10.3390/cancers14174143
3. Management of Recurrent Venous Thromboembolism on Anticoagulation.
   Eatrides J, Singh A, Patel A, Jaglal M, et al · · 2026 · PMID 42123146 · DOI 10.3390/jcm15093415