Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Condition: Cost Sharing, Acute Coronary Syndrome
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the
      impact of copayment reduction on clinician choice of medication, patient adherence, and
      clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical
      trial that will assess the impact of copayment reduction by equalizing the copayment of
      clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication
      adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket
      cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment
      reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk.
      This is in part due to greater adherence to an evidence--based secondary prevention
      medication. Additionally the reduction in MACE may reflect greater selection of a more potent
      antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as
      provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment
      rather than the cost burden to the patient.
    

Detailed description: 
      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.
    

Intervention name(s): Study voucher card
Intervention type(s): Other
Intervention description(s): Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Acute Coronary Syndromes, ACS, Myocardial Infarction, STEMI, NSTEMI, MI, Co-Payments, Copay, Cost Sharing