Chip Faircloth, EVP
INTERVENT to Participate in Multi-Center Study to Test Ways to Prevent a Second Stroke in Patients with a Narrowed Brain Artery
Telehealth lifestyle coaching program to be used by patients across 115 medical centers as part of landmark NIH-funded clinical trial
Savannah, Georgia (March 30, 2022) - INTERVENT International ("INTERVENT") has been selected to provide its telehealth lifestyle coaching program to all participants in the National Institutes of Health (NIH)-funded Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis, or CAPTIVA, clinical trial.
CAPTIVA will test whether two prospective therapies prevent recurrent stroke better than the standard of care in patients with intracranial arterial stenosis, or severe narrowing of an artery in the brain. Intracranial arterial stenosis accounts for 8% to 10% of all strokes in the U.S. Worldwide, it is one of the most common causes of stroke and is particularly prevalent in Black, Asian and Hispanic populations. What further compounds the problem is that, if a person has had a stroke from this disease, their risk of a recurrent stroke is much higher than for other causes of stroke.
Funded for $38.3 million over a five-year period by the NIH, CAPTIVA will enroll 1,683 patients across 115 NIH StrokeNet sites. The NIH StrokeNet was created to maximize the efficiency of multi-site trials focused on stroke prevention, treatment and recovery. Marc Chimowitz, M.B.Ch.B., a professor of neurology at the Medical University of South Carolina (MUSC), and Brian Hoh, M.D., chair of neurosurgery at the University of Florida, will co-lead the trial.
Dr. Chimowitz previously led the NIH-funded Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis, or SAMMPRIS, multi-center clinical trial, which provided the basis for the current standard of care. SAMMPRIS showed that intensive medical management of risk factors along with dual antiplatelet therapy with aspirin and clopidogrel prevented recurrence of stroke in these patients much better than stents.
However, SAMMPRIS results showed that the best outcomes were seen in patients who had had only transient ischemic attacks prior to enrollment. Among those who had had strokes prior to enrollment, over 20% of patients experienced a recurrent stroke due to a blood clot, bleeding in the brain or vascular death within one year, despite being treated with intensive management of risk factors and the combination of aspirin and clopidogrel.
"Clearly there is a need for better treatment for this disease," said Dr. Hoh, co-leader of the CAPTIVA trial. "Although symptomatic intracranial arterial stenosis is common and has a poor prognosis, only a few large randomized therapeutic trials have been conducted in these patients. Despite its importance, it is an understudied disease compared with other cerebrovascular conditions such as carotid artery stenosis and atrial fibrillation."
CAPTIVA will begin where SAMMPRIS left off by studying patients with severe narrowing of an artery in their brains who have also had strokes. CAPTIVA will determine whether two new prospective anti-blood clotting therapies — aspirin plus either ticagrelor (also known as Brilinta) or rivaroxaban (also known as Xarelto) — are more effective at reducing the risk of a second stroke than aspirin plus clopidogrel and whether they lead to an increased risk of bleeding. As part of the double-blind, randomized clinical trial, patients will be treated with one of the three combination therapies for one year.
In addition to receiving one of the three combinations of anti-clotting medications, all patients will undergo intensive medical management and work with a professional health coach to make lifestyle modifications. Tanya Turan, M.D., professor of neurology at MUSC, will oversee the coordination of intensive medical management for the nationwide trial. INTERVENT will provide the lifestyle health coaching.
"Intensive management of vascular risk factors, such as high blood pressure, raised cholesterol, diabetes, smoking and physical inactivity, is key for reducing the risk of stroke in patients with a narrowed brain artery or other causes of stroke," said Dr. Turan. "The CAPTIVA trial provides protocols for intensive management of vascular risk factors for all patients enrolled in the trial to lower their risks of stroke."
INTERVENT's telehealth lifestyle coaching program, which will be provided to all enrolled patients, addresses education on stroke risk factor reduction and management and behavior change processes to help patients eat healthfully, be physically active, manage weight, cope with stress and, if applicable, give up tobacco.
Neil Gordon, M.D., Ph.D., M.P.H., INTERVENT's CEO, says, "CAPTIVA is the third multi-center NIH-funded stroke risk reduction study to use INTERVENT's evidence-based telehealth coaching program to assist patients in making and adhering to meaningful lifestyle changes. The first study, SAMMPRIS, resulted in publications in the New England Journal of Medicine and Lancet and helped establish the value of telehealth coaching when used in collaboration with stroke neurologists to reduce cerebrovascular events in patients with intracranial arterial stenosis. The second study, the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial, or CREST-2, involving patients from over 140 medical centers, is currently in progress." He also stated that "Like these two earlier studies, patients in CAPTIVA will receive the highest-quality, intensive medical management to facilitate stroke risk reduction. We could not be more excited about participating in this new landmark clinical trial and, in the process, helping both to further scientific knowledge and benefit the health of individuals at risk for recurrent stroke."
INTERVENT International is a physician-led, global, technology-driven, behavior change and population health management company that provides its services primarily via digital and telehealth approaches. INTERVENT develops, licenses and provides evidence-based, technology-enabled, data-driven programs for the prevention and management of multiple chronic diseases and cost-drivers. INTERVENT's programs have been proven effective in more than 120 published scientific abstracts and manuscripts, including randomized and independently-conducted clinical trials published in prestigious peer-reviewed scientific journals. More than two million individuals have participated in INTERVENT's programs. INTERVENT's digital/telehealth coaching program is currently being used by all participants in the NIH-funded CREST-2 multi-center clinical trial and the Public Health Agency of Canada-funded Canadian Diabetes Prevention Program.
For more information, please visit www.interventhealth.com or email firstname.lastname@example.org.