CLINICAL
NEWS IN FOCUS
3 Ways
to read the news magazines
of the American College
of Cardiology:
Novel New Study Could Finally Hold Answers
to Questions about Aspirin Dosing
W
hile aspirin is widely used to prevent
heart attacks and strokes in people with
cardiovascular disease, research has yet
to definitively determine the dose that works best
while minimizing potentially serious side effects like
internal bleeding. A new, large-scale pragmatic clinical trial conducted through PCORnet, an initiative
of the Patient-Centered Outcomes Research Institute
(PCORI), has the potential to put an end to these
questions once and for all.
ADAPTABLE (Aspirin Dosing: A Patient-centric
Trial Assessing Benefits and Long-Term Effectiveness), which is expected to begin enrolling patients
this spring, will compare benefits and risks of two
commonly used daily doses of aspirin—low-dose
81 mg and regular strength 325 mg—in as many as
20,000 patients with cardiovascular disease. Patients
will be enrolled over 24 months with a maximum
follow-up of 30 months and randomized to receive
one of the two doses. Researchers also will compare
the effects of aspirin in certain patient populations
“We are striving to
answer an important
clinical question that
interests both patients
and providers in a highly
efficient way that takes
advantage of data that
is already being collected
as part of routine care.”
– Robert A. Harrington, MD
38 CardioSource WorldNews
based on gender, age, and racial- and ethnic-minority
affiliation and in patients with and without diabetes
or chronic kidney disease.
What makes ADAPTABLE unique is that it will
leverage PCORNet’s networks of electronic health
records (EHRs) to more quickly identify, enroll and
follow a broad population and range of patients in a
variety of clinical settings ranging from large health
care systems to smaller practices. The trial will be
led by researchers at Duke University and involve researchers, clinicians and patients at 7 PCORnet partner networks, 6 of which are based in large health
systems, and 1 operated by a patient-led group.
In addition, the trial is expected to cost much
less than a more conventional trial and be far more
efficient. For example, researchers will have direct access to clinical data vs. needing to re-enter data into a
parallel research database. “We are striving to answer
an important clinical question that interests both
patients and providers in a highly efficient way that
takes advantage of data that is already being collected
as part of routine care,” says Robert A. Harrington,
MD, co-chair of ADAPTABLE. “It’s truly better integrating research into clinical practice and helping in
the construct of the learning health care system.”
Another highlight of ADAPTABLE is that it
includes patient involvement every step of the way.
According to Matthew Roe, MD, MHS, co-principal
investigator for the trial, the trial includes targeted
electronic outreach and electronic follow-up with patients in order to ultimately provide answers to questions like ‘How much aspirin should be taken each
day to reduce risks of heart attack or stroke’ and/or
‘Do benefits and risks differ based on dose, health,
age or other circumstance’? Patient engagement is a
key and defining aspect of this trial.
“We’re excited to be part of the first trial conducted through PCORnet which is a national research
network that unites patients, clinicians, health
systems and electronic health records to improve
patient-centered outcomes,” said Adrian F. Hernandez, MD, MHS, director of outcomes and health
services research at the Duke Clinical Research
Institute and PCORnet’s Coordinating Center Principal Investigator. “Heart disease is the leading cause
of death for men and women in the United States.
The results of this study will help patients and those
who care for them make better decisions about how
aspirin therapy might be most helpful and ultimately
could prevent as many as 88,000 death per year
worldwide.”
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Learn more about ADAPTABLE at TheAspirinStudy.org.
March 2016