VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization

NCT06873321 | Recruiting Phase 4 DMC

• 1 other identifier: CAAE: 77069024.9.0000.8807
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures. Sometimes, extended prophylaxis for VTE with KLMWH or direct oral anticoagulants (DOACs) is necessary. Currently, there is no consensus in the literature regarding the use of DOACs for extended VTE prophylaxis in patients undergoing lower limb revascularization (LLR). Objective: To evaluate the use of DOACs (already approved to reduce MACE and MALE) in VTE prophylaxis in patients undergoing LLR.

Conditions

Peripheral Arterial Disease; Venous Thormboembolism; Cardiovascular Diseases; Vascular Surgery Patient with PAD / Carotid Stenosis

Keywords

Peripheral Arterial Disease; chronic limb-threatening ischemia; Deep Vein Thrombosis; venous thromboembolism; Factor Xa Inhibitors; rivaroxaban

Outcome Measures

Primary Outcomes (2)

• primary efficacy outcome

  Incidence of symptomatic + asymptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) 30 days post-hospital discharge.

  30 days

• primary safety outcome

  Combination of clinically relevant non-major bleeding + major bleeding defined by the ISTH criteria

  30 days

Study Arms (2)

study arm

EXPERIMENTAL

Rivaroxaban 2.5 mg bid + aspirin 100 mg

Drug: rivaroxaban 2.5 mg bid + aspirin 100 mg

comparator

ACTIVE COMPARATOR

clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures

Drug: clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures

Interventions

rivaroxaban 2.5 mg bid + aspirin 100 mg DRUG

rivaroxaban 2.5 mg bid + aspirin

study arm

clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures DRUG

comparator

comparator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be adults of any age and gender.
• Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC/EBSERH - UFPE.
• Sign the informed consent form (ICF) (Appendix 2).

You may not qualify if:

• Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation.
• Have any contraindications to Rivaroxaban.
• Do not return for the 30-day postoperative follow-up visit.

Sponsors & Collaborators

• Science Valley Research Institute: lead

Study Sites (1)

Hospital das Clínicas, Federal University of Pernambuco

Pernambuco, Pernambuco, 50740-900, Brazil

RECRUITING

Related Publications (7)

• Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.

  PMID: 32222135 BACKGROUND

• Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Störk S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27. PMID: 28844192. Copy

  BACKGROUND

• Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, Samama CM. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e227S-e277S. doi: 10.1378/chest.11-2297.

  PMID: 22315263 BACKGROUND

• Haykal T, Zayed Y, Kerbage J, Deliwala S, Long CA, Ortel TL. Meta-analysis and systematic review of randomized controlled trials assessing the role of thromboprophylaxis after vascular surgery. J Vasc Surg Venous Lymphat Disord. 2022 May;10(3):767-777.e3. doi: 10.1016/j.jvsv.2021.08.019. Epub 2021 Sep 8.

  PMID: 34508872 BACKGROUND

• Dagher NN, Modrall JG. Pharmacotherapy before and after revascularization: anticoagulation, antiplatelet agents, and statins. Semin Vasc Surg. 2007 Mar;20(1):10-4. doi: 10.1053/j.semvascsurg.2007.02.006.

  PMID: 17386359 BACKGROUND

• Chindamo MC, Marques MA. Bleeding risk assessment for venous thromboembolism prophylaxis. J Vasc Bras. 2021 Apr 28;20:e20200109. doi: 10.1590/1677-5449.200109.

  PMID: 34093680 BACKGROUND

• de Oliveira Buril G, Portugal MF, Neves S, da Silva VS, Sad EF, Caffaro RA, Volpiani GG, Bernardi WH, Leal IZ, Pimentel TF, Simoni GH, Lins EM, Ramacciotti E. Venous Thromboembolism in Patients Receiving Rivaroxaban Plus Aspirin or Standard Treatment after Lower Limb Revascularization-Rationale and Design of the RESOLUTION Trial. Ann Vasc Surg. 2025 Nov 11;124:22-27. doi: 10.1016/j.avsg.2025.10.041. Online ahead of print.

  PMID: 41232756 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases; Carotid Stenosis; Chronic Limb-Threatening Ischemia; Venous Thrombosis; Venous Thromboembolism

Interventions

Rivaroxaban; BID protein, human; Aspirin; Clopidogrel; Endovascular Procedures

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Thrombosis; Embolism and Thrombosis; Thromboembolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Eduardo Ramacciotti, MD, Ph.D.

  Science Valley

  STUDY DIRECTOR

Central Study Contacts

Gabriela Oliveira Buril, MD

CONTACT

+5581991121872; gabriela.buril@ufpe.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Doppler evaluators will be blinded to the study treatment arms
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: February 24, 2024
• Primary Completion: July 20, 2025
• Study Completion: July 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)