Feature | Coronavirus (COVID-19) | December 23, 2020

NIH Pauses Anticoagulant Trial For Critically Ill COVID-19 Patients

Therapeutic anticoagulation trials is looking at which blood thinners are best to use to treat COVID-caused venous thrombosis embolism (VTE)

Thrombus formation in the aortic arch in a 46-year-old COVID patients in the ICU. Three trials are underway to find which anticoagulant strategy is best to treat moderate and critically ill patients where COVID-causes venous thrombo-embolism (VTE) is a major cause of complications. Image courtesy of Margarita Revzin et al.

Thrombus formation in the aortic arch in a 46-year-old COVID patients in the ICU. Three trials are underway to find which anticoagulant strategy is best to treat moderate and critically ill patients where COVID-causes venous thrombo-embolism (VTE) is a major cause of complications. Image courtesy of Margarita Revzin et al. 


December 23, 2020 — Three clinical trial platforms working together to test the effects of full doses of anticoagulants in COVID-19 patients have paused enrollment for one group of patients. Among critically ill COVID-19 (SARS-CoV-2) patients requiring intensive care unit (ICU) support, therapeutic anticoagulation drugs did not reduce the need for organ support. Enrollment continues for moderately ill hospitalized COVID-19 patients in the trials. 

As is normal for clinical trials, these trials are overseen by independent boards that routinely review the data and are composed of experts in ethics, biostatistics, clinical trials, and blood clotting disorders. Informed by the deliberations of these oversight boards, all the trial sites have paused enrollment of the most critically ill hospitalized patients with COVID-19. A potential for harm in this sub-group could not be excluded. Increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to undertake additional analyses that will be made available as soon as possible.   

At the recommendation of the oversight boards, patients who do not require ICU care at the time of enrollment will continue to be enrolled in the trial. Whether the use of full-dose compared to low-dose blood thinners leads to better outcomes in hospitalized patients with less severe COVID disease remains a very important question. Patients who require full-dose blood thinners for another medical indication are not included in these trials.

COVID Causes Widespread Blood Clots, Leading to Serious Complications

COVID-19 is associated with significant inflammation and clinical and pathologic evidence of widespread blood clots. This venous thrombosis embolism (VTE) can cause stroke, heart attacks, pulmonary embolism (PE), deep vein thrombosis (DVT) and organ failure. These NIH trials were launched because clinicians have observed that many patients ill with COVID-19, including those who have died from the disease, formed blood clots throughout their bodies, even in their smallest blood vessels.  

Examples of kidney infarct organ damage caused by COVID-caused clotting.

Example of kidney infarct organ damage caused by COVID-caused clotting in a 57-year-old man with COVID-19 who presented with abdominal pain. Image courtesy of Margarita Rezvin et al. 

Three Trials Looking at Anticoaguation Strategies to Prevent COVID Bloot Clots

Three international partners have come together in an unprecedented collaboration resulting in a multiple platform randomized controlled trial. The three international trials include: the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient;  and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC). 

The trials which span four continents have the common goal of assessing the benefit of full doses of blood thinners to treat moderately ill or critically ill adults hospitalized for COVID-19, compared to a lower dose often used to prevent blood clots in hospitalized patients. To meet the challenge of this pandemic, investigators worldwide joined forces to answer this question as rapidly as possible. In the United States, the ACTIV-4 trial is being led by a collaborative effort with several universities, including the University of Pittsburgh and New York University, New York City. 

The trials are supported by multiple international funding organizations including the Canadian Institutes of Health Research, the National Institute for Health Research (U.K.), the National Health and Medical Research Council (Australia), the National Institutes of Health (U.S.), and the PREPARE and RECOVER consortia (EU).

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information: www.nhlbi.nih.gov
 

Related Content

News | Antiplatelet and Anticoagulation Therapies
October 4, 2021 — One month of dual antiplatelet therapy (DAPT) following stent implantation in high bleeding risk ...
Home October 04, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

September 1, 2021 — The STOPDAPT-2 ACS trial does not support the use of one month of dual antiplatelet therapy (DAPT) ...

Home September 01, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

September 1, 2021 – The anticoagulant edoxaban (Savaysa) may be just as effective as warfarin for preventing heart ...

Home September 01, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

June 21, 2021 — The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim's dabigatran etexilate ...

Home June 21, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

May 15, 2021 — The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in ...

Home May 15, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

April 28, 2021 — An analysis of the prospective Chinese Fuwai PCI Registry, confirms long-term, dual-antiplatelet ...

Home April 28, 2021
Home
Feature | Antiplatelet and Anticoagulation Therapies | By Dave Fornell, Editor

A comprehensive review or more than 80 randomized controlled trials (RCTs) investigating how to best manage optimal ...

Home March 22, 2021
Home
Videos | Antiplatelet and Anticoagulation Therapies

The COMPARE CRUSH Trial looked at the effect of per-hospital crushed prasugrel tablets in patients with STEMI planned ...

Home October 19, 2020
Home
Videos | Antiplatelet and Anticoagulation Therapies

Roxana Mehran, M.D., and Marco Valgimiggle, M.D., present the results of the Xience 90/28 trials that evaluated the use ...

Home October 19, 2020
Home
Videos | Antiplatelet and Anticoagulation Therapies

Gregg Stone, M.D., presents the results of a pooled analysis of randomized trials of bivalirudin virus heparin in acute ...

Home October 17, 2020
Home
Subscribe Now