Peripheral Arterial DiseasePhase 4RESOLUTIONNCT06873321
VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
A Phase 4 study testing rivaroxaban 2.5 mg bid + aspirin 100 mg and clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures in people with Peripheral Arterial Disease and Venous Thormboembolism, run by Science Valley Research Institute at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Venous Thormboembolism, Cardiovascular Diseases
- What is being tested?
- rivaroxaban 2.5 mg bid + aspirin 100 mg and clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Feb 2024to 30 Jul 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas, Federal University of Pernambuco
Pernambuco, Pernambuco, 50740-900
Gabriela Oliveira Buril, MD, +5581991121872, gabriela.buril@ufpe.br
Gabriela Oliveira Buril, MD
About this study
Official title: Incidence of Venous Thromboembolism After Lower Limb Revascularization in Patients Receiving Rivaroxaban 2.5 Mg Bid + Aspirin 100 Mg Versus Single Antiplatelet Treatment - a Randomized Clinical Trial
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.
Read the detailed description
The goal of this clinical trial is to evaluate the 30-day VTE incidence in patients submitted to endovascular or open surgery for lower limbs revascularization treated with either rivaroxaban 2.5 mg bid + aspirin 100 mg or single antiplatelet agents (SoC). The main questions it aims to answer are:
Does rivaroxaban 2.5 mg + aspirin reduce the incidence of 30-day VTE?
Researchers will compare rivaroxaban 2.5 mg bid + aspirin 100 mg to a single antiplatelet agent to check comparative VTE incidence.
Participants will:
Take either rivaroxaban 2.5 mg bid + aspirin continuously or single antiplatelet agent (clopidogrel for 3 months followed by aspirin 100 mg for endovascular procedures or aspirin for oper procedures) Visit the clinic once every 2 weeks for checkups and tests, and a mandatory Doppler ultrasound at day 30 Keep a diary of their symptoms
Study Population The study population will consist of patients hospitalized in the vascular surgery ward at the Hospital das Clínicas/Brazilian Hospital Services Company-Federal University of Pernambuco (HC/EBSERH-UFPE) who undergo arterial revascularization surgery of the lower limbs (LL) via angioplasty (ATP) or bypass surgery.
The study will determine the sample size by the criteria established by Resolution 466/12 of the National Health Council. The estimated sample size is 200 research participants, with 100 in the study group and 100 in the control group. If the degree of dispersion is high, the number of research participants may be adjusted.
Study Design A single-center randomized clinical trial. Randomization will be performed using the REDCap platform. Due to the nature of the procedure, blinding will not be possible.
Considering an acceptable margin of error (5%), a confidence level of 95%, and a prevalence of 50% for venous diseases, with a heterogeneity level of 50%.
Selection of Research Participants The selection of research participants will follow specific inclusion and exclusion criteria. After selection, participants will be randomly assigned to the Study Group (SG) or the Control Group (CG).
CG (Control Group): Will receive standard treatment as described in the literature: Aspirin (ASA) 100 mg once daily for patients undergoing lower limb bypass revascularization, and ASA 100 mg once daily combined with Clopidogrel 75 mg once daily for patients undergoing lower limb angioplasty.
SG (Study Group): Will receive ASA 100 mg once daily plus Rivaroxaban 2.5 mg twice daily for patients undergoing bypass or angioplasty revascularization.
A total of 100 patients will be included in the study, equally divided between the control and study groups. Randomization will be performed via the REDCap platform.
- Conditions
- Peripheral Arterial Disease, Venous Thormboembolism, Cardiovascular Diseases, Vascular Surgery Patient with PAD / Carotid Stenosis
- Being tested
- rivaroxaban 2.5 mg bid + aspirin 100 mg, clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
- Keywords
- Peripheral Arterial Disease, chronic limb-threatening ischemia, Deep Vein Thrombosis, venous thromboembolism, Factor Xa Inhibitors, rivaroxaban
- Medical subject headings
- Peripheral Arterial Disease, Cardiovascular Diseases, Carotid Stenosis, Chronic Limb-Threatening Ischemia, Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxaban 2.5 mg bid + aspirin 100 mgDrug
rivaroxaban 2.5 mg bid + aspirin
clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open proceduresDrug
comparator
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | Rivaroxaban 2.5 mg bid + aspirin 100 mg Receives: 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 Receives: Drug: clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary efficacy outcome
Incidence of symptomatic + asymptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) 30 days post-hospital discharge.
Measured: 30 days
primary safety outcome
Combination of clinically relevant non-major bleeding + major bleeding defined by the ISTH criteria
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start24 Feb 2024
- Primary completion20 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science Valley Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Ramacciotti, MD, Ph.D., Study director, Science Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873321
- Sponsor's protocol ID
- CAAE: 77069024.9.0000.8807
- Other IDs
- CAAE: 77069024.9.0000.8807
- Acronym
- RESOLUTION
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed based on scientific merit. After a proposal is approved, data can be shared through a secure online platform after signing a data access agreement.
Publications
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.
PubMed 32222135Eikelboom 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
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.
PubMed 22315263Haykal 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.
PubMed 34508872Dagher 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.
PubMed 17386359Chindamo MC, Marques MA. Bleeding risk assessment for venous thromboembolism prophylaxis. J Vasc Bras. 2021 Apr 28;20:e20200109. doi: 10.1590/1677-5449.200109.
PubMed 34093680de 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. 2026 Mar;124:22-27. doi: 10.1016/j.avsg.2025.10.041. Epub 2025 Nov 11.
PubMed 41232756