Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial (MICHELLE)
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| ClinicalTrials.gov Identifier: NCT04662684 |
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Recruitment Status :
Completed
First Posted : December 10, 2020
Last Update Posted : April 6, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 Venous Thromboembolism | Drug: Rivaroxaban 10 MG | Phase 3 |
Background: The devastating 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 VTE prophylaxis.
Design: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg OD 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, with a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge.
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 320 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg OD 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, with a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge. |
| Masking: | None (Open Label) |
| Masking Description: | open-label |
| Primary Purpose: | Prevention |
| Official Title: | Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial |
| Actual Study Start Date : | October 16, 2020 |
| Actual Primary Completion Date : | July 10, 2021 |
| Actual Study Completion Date : | August 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Rivaroxaban
Rivaroxaban 10mg OD for 35+/- 4 days post-hospital discharge
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Drug: Rivaroxaban 10 MG
No intervention
Other Name: No intervention |
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No Intervention: No intervention
control
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- Venous thromboembolism and VTE related-death [ Time Frame: at day 35 +/- post hospital discharge ]a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge
- Major bleeding [ Time Frame: at day 35 +/- post hospital discharge ]Incidence of major bleeding according to ISTH criteria.
- A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death. [ Time Frame: at day 35 +/- post hospital discharge ]A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death.
- Days alive out of the hospital (DAOH) at 35 +/-4 days [ Time Frame: at day 35 +/- post hospital discharge ]Days alive out of the hospital (DAOH) at 35 +/-4 days
- D-dimer (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]plasma level of D-dimers in ng/mL
- C reactive protein (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]plasma level of C Reactive Protein in μg/mL
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and nonpregnant female patients 18 years of age or older
- Positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample
- Pneumonia confirmed by chest imaging
- Additional risk factors for VTE, as indicated by a total modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) risk score of 4 or higher
- Have received thromboprophylaxis with low-molecular-weight heparin, fondaparinux, or unfractionated heparin during the index hospitalization
Exclusion Criteria:
- Age < 18 years
- Refusal of informed consent
- Physician decision that involvement in the trial was not in the patient's best interest
- Patients with a medical indication for anticoagulation therapy at the time of inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)
- Platelets < 50,000 / mm3
- Patients with contraindications to anticoagulation (active bleeding, liver failure, blood dyscrasia, or prohibitive hemorrhagic risk in the investigator's assessment)
- Active cancer (excluding non-melanoma skin cancer) defined as cancer, not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy.
- Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or glycoprotein P (P-gp) (eg protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong inducers of CYP3A4 (how but not limiting rifampicin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine or St. John's wort)
- Creatinine clearance <30 ml / min
- Pregnancy or breastfeeding
- known HIV infection
- Presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ECG confirmed acute ischemia or myocardial infarction, and/or clinically significant dysrhythmia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662684
| Brazil | |
| Science Valley Research Institute | |
| Santo André, São Paulo, Brazil, 09030370 | |
| Study Chair: | Eduardo Ramacciotti, MD, Ph.D | Science Valley Research Institute | |
| Study Director: | Leandro Agati, PhD | Science Valley Research Institute |
Publications of Results:
Other Publications:
| Responsible Party: | Eduardo Ramacciotti, Principal Investigator, Science Valley Research Institute |
| ClinicalTrials.gov Identifier: | NCT04662684 |
| Other Study ID Numbers: |
21589 Michelle Trial |
| First Posted: | December 10, 2020 Key Record Dates |
| Last Update Posted: | April 6, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Red Cap open file |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Covid19 Venous Thromboembolism Direct oral anticoagulants Rivaroxaban |
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COVID-19 Thrombosis Thromboembolism Venous Thromboembolism Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Rivaroxaban Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |