ArticleAmerican heart journal2021
Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.
Article in American heart journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04662684 (Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial
Who cites it
13 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Standard- versus extended-duration anticoagulation for primary venous thromboembolism prophylaxis in acutely ill medical patients.The Cochrane database of systematic reviews · 2024Pooled it
- Prophylactic anticoagulants for non-hospitalised people with COVID-19.The Cochrane database of systematic reviews · 2023Pooled it
- American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: July 2021 update on postdischarge thromboprophylaxis.Blood advances · 2022Guideline
- Incidence of venous thromboembolic events in COVID-19 patients after hospital discharge: A systematic review and meta-analysis.Thrombosis research · 2022Pooled it
- Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.Lancet (London, England) · 2022Trial
- Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.Journal of the American Heart Association · 2021Trial
- Thromboprophylaxis and clinical outcomes in moderate COVID-19 patients: A comparative study.Research in social & administrative pharmacy : RSAP · 2022Article
- Commentary on the 2021 ASH Guidelines on use of anticoagulation in patients with COVID-19 being discharged from the hospital.Blood advances · 2022Article
- Venous Thromboembolic Disease in COVID-19, Pathophysiology, Therapy and Prophylaxis.International journal of molecular sciences · 2022Review
- Biomarker derived risk scores predict venous thromboembolism and major bleeding among patients with COVID-19.Research and practice in thrombosis and haemostasis · 2022Article
- Clinical update on COVID-19 for the emergency and critical care clinician: Medical management.The American journal of emergency medicine · 2022Review
- The Role of Heparin in COVID-19: An Update after Two Years of Pandemics.Journal of clinical medicine · 2022Review
- Anticoagulation in Patients With COVID-19: JACC Review Topic of the Week.Journal of the American College of Cardiology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis.
designThis study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. SUMMARY: The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.