PREVENT-HD randomized, controlled, remote clinical trial studied efficacy of rivaroxaban in preventing venous and arterial thrombosis, hospitalization and death – data published in Circulation
Because millions of people experience fatal venous and arterial thrombosis – blood clots – per year and those with COVID-19 are at higher risk, researchers at The Feinstein Institutes for Medical Research helped to design and implement an entirely virtual, outpatient, cloud-based clinical trial to understand the efficacy of a common prophylactic medication: rivaroxaban. While the PREVENT-HD multi-center site clinical trial found no significant impact of rivaroxaban to prevent clots, the findings - along with its novel remote trial design -were published today in the journal Circulation.
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Mark Goldin, MD, (left) and Alex Spyropoulos, MD, (right) led the study. (Credit: Feinstein Institutes)
“Since the start of the pandemic, we have been studying COVID-19, its risk to increase blood clots and the best course of treatment, both in and out of the hospital,” said Alex C. Spyropoulos, MD, study co-principal investigator, professor at the Feinstein Institutes’ Institute of Health System Science and director of anticoagulation and clinical thrombosis services at Northwell Health. “The PREVENT-HD trial is a good model for how future outpatient clinical trials can be designed, harnessing patient data and embracing technology.”
From August 2020 to April 2022, more than 1,280 diverse, COVID-19-positive, symptomatic patients were virtually consented and enrolled in the trial. The patients were identified through electronic health records and other clinical decision support tools, which helped detect patients at risk of a venous or arterial thrombosis event. Rivaroxaban was prescribed daily for 35 days, but the results show that it did not reduce the frequency of a composite outcome of symptomatic majorthromboembolism, hospitalization and death. Rivaroxaban did reduce thrombosis in an exploratory analysis. The trial was terminated early due to under-enrollment, but the data did not appear to support routine antithrombotic prophylaxis in non-hospitalized patients with symptomatic COVID-19.
“While the trial was unable to show benefit with low-dose rivaroxaban to prevent adverse events that included clotting, hospitalization and death, it contributed valuable insights for the management of outpatients with COVID-19 and co-existing cardiovascular risk factors,” said Mark Goldin, MD, principal investigator of the study and Northwell’s co-director of anticoagulation services and director of clinical trials in the department of medicine. “Northwell is a leading center worldwide in elucidating blood clot prevention strategies in COVID-19 patients during the full continuum of care: hospital admission, after hospital discharge and in the community.”
Despite pandemic-related logistical challenges, the PREVENT-HD’s model allowed for 100 percent follow-up of all patients through day 49. Additionally, the remote design allowed for nearly 30 percent of the trial’s participants to be non-white in an effort to enroll diverse patient populations.
“Despite everything we now know about COVID-19, major questions remain about why it can cause dangerous blood clots,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “Drs. Spyropoulos and Goldin’s important work into novel clinical trials serves as a model for conducting impactful research, even during a global pandemic.”
Dr. Spyropoulos is a world-renowned expert in blood clots who has collaborated with researchers across the globe, particularly during the pandemic, to study clots in COVID-19 patients. During a Late Breaking Clinical Trial Presentation at the 2022 American Heart Association’s Scientific Sessions, he shared data from a large clinical trial he and Dr. Goldin led, showing the effectiveness of a new digital tool, called IMPROVE-DD VTE, that assesses and decreases the risks of these blood clots – both during hospitalization and post-discharge period – as well as provide life-saving preventative therapy.
In 2021, Drs. Spyropoulos and Goldin published in the Journal of American Medical Association (JAMA) Internal Medicine results from his HEP-COVID clinical trial, which revealed that prophylaxis with therapeutic low-dose heparin significantly reduces major thromboembolism (clotting) and death in high-risk hospitalized patients versus standard-of-care thromboprophylaxis.
About the Feinstein Institutes
The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.
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Contacts
Julianne Mosher Allen
516-880-4824
jmosherallen@northwell.edu