Management of Acute Stroke Patients on Treatment with New Oral Anticoagulants: Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry
Clinical practice for the management of non-valvular atrial fibrillation (AF) is rapidly changing. While vitamin K antagonist (warfarin) has been the most widely used anticoagulant for decades, long-term warfarin therapy involves multiple food and drug interactions, frequent blood testing and dose adjustment, requirements that make it cumbersome to use for many patients. This has led to the quest of new oral anticoagulants that are effective, safe and convenient to use in clinical practice.
Between 2010 and 2012, three new oral anticoagulants (dabigatran, rivaroxaban, and apixaban) were approved by US Food and Drug Administration (FDA) for stroke prophylaxis in AF patients. Despite their efficacy showed in randomized clinical trials, patients on these novel agents still are at risk for a stroke. Results from RE-LY, ARISTOTLE, and ROCKET-AF trials found between 1-2% of treated patients in the trials have an ischemic stroke. While less common than on warfarin therapy, up to 0.5% of patients on a novel anticoagulant will have a hemorrhagic stroke per year. Yet the optimal management of patients who experienced either an acute ischemic stroke (AIS) or intracerebral hemorrhage (ICH) while on novel anticoagulants remains unclear. With the rapid adoption of new oral anticoagulants in the United States, clinicians will inevitably face this therapeutic dilemma.
What is ARAMIS?
The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulants in community practice. Building upon the existing infrastructure of the nation's largest ongoing stroke registry (American Heart Association/American Stroke Association Get With The Guidelines-Stroke), the ARAMIS registry will be a multicenter, prospective, observational study of AIS and ICH patients on home anticoagulation therapy. Key data points will be abstracted from the medical records of approximately 15,000 patients from approximately 200 Get With The Guidelines®- Stroke (GWTG-Stroke) hospitals over 3 to 5 years. Using an efficient study design, the ARAMIS registry will complement the results of both randomized controlled clinical trials and current GWTG-Stroke registry in addressing several key treatment management issues surrounding patients with either AIS or ICH on novel anticoagulant therapies. In particular, attention will be focused on coagulation tests, safety of thrombolytic therapy for AIS, treatment patterns of ICH, and clinical outcomes for AIS and ICH patients on novel oral anticoagulants. The acquisition of such findings would be critical important because it would help fill in gaps on guideline recommendations and provide insights into the management of AIS and ICH patients on treatment with new anticoagulants. This will allow physicians to feel more secure in their use of the novel agents while improving the care and outcomes of patients on these agents who have complications.
- Describe and characterize diagnostic tests being used to assess level of anticoagulation when a patient comes in with AIS or ICH on one of the novel agents
- Examine the utilization and safety profile of thrombolytic therapy in AIS patients on new oral anticoagulants as compared with those on warfarin
- Document current practice patterns for the care of ICH due to oral anticoagulants and determine how treatment and clinical outcomes vary by novel anticoagulants and warfarin therapy
The ARAMIS registry is designed as an efficient and scalable clinical research platform for stroke patients on oral anticoagulant therapy. In addition to standard ARAMIS data collection, optional Lab and Follow-up module will be available to selected sites for specialized anticoagulation assays in central core laboratory and longitudinal assessment of medication adherence and clinical outcomes. By building on this existing infrastructure, site start up, information burden and resources will be minimized, speeding up the registry start-up time while drastically reducing the total cost of ARAMIS registry.
For more information about ARAMIS contact [email protected].