Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study

ARTEMIS is a prospective, cluster-randomized clinical trial that will evaluate whether
patient copayment elimination significantly influences antiplatelet therapy selection and
long-term adherence, as well as patient outcomes and overall cost of care after acute
myocardial infarction. Approximately 11,000 patients with ST-elevation myocardial infarction
(STEMI) or non-STEMI (NSTEMI) will be enrolled at the approximately 300 hospitals in this
study. Study sites selected for ARTEMIS will be geographically diverse, and will represent a
diversity of hospital types and capabilities (e.g., teaching hospital, community hospital,
etc). After institutional review board (IRB) approval of the study, each hospital will be
randomized into either the intervention arm or the control arm. Hospitals randomized to the
intervention arm will have the opportunity to offer enrolled patients either clopidogrel
(generic P2Y12 receptor inhibitor option) or ticagrelor (brand P2Y12 receptor inhibitor
option) without patient contribution to copayment in the next 12 months after the index MI
discharge. Hospitals in the control arm will provide care per usual clinical routine.
Notably, for both intervention and control arms, all patient management decisions (including
the choice of antiplatelet therapy) are completely at the discretion of the care providers.
Duration of antiplatelet therapy will also be at the discretion of care providers. All
enrolled patients will be followed up to 15 months after index MI discharge to collect data
on longitudinal treatment patterns and outcomes. Primary and secondary endpoints will be
assessed at 12 months. An additional three months of follow up will assess for antiplatelet
persistence and clinical events after discontinuation of the copayment intervention.
Centralized follow-up will be conducted every 3 months via telephone or web-based contact.

Inclusion Criteria:

Patients are eligible to be included in the study if they meet all of the following
criteria:

- are ≥ 18 years of age

- have been diagnosed with STEMI or NSTEMI during the index hospitalization

- be treated with a P2Y12 receptor inhibitor at the time of enrollment

- have U.S. based health insurance coverage with prescription drug benefit

- have been fully informed and are able to provide written consent for longitudinal
follow-up

Exclusion Criteria:

Patients are excluded if they meet any of the following criteria:

- have a history of prior intracranial hemorrhage

- have any contraindications to P2Y12 receptor inhibitor therapy at discharge

- involvement in another research study that specifies the type and duration of P2Y12
receptor inhibitor use within the next 12 months.

- have a life expectancy of less than one year

- have plans to move outside the US in the next year