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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02406677
Recruitment Status : Completed
First Posted : April 2, 2015
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cost Sharing, Acute Coronary Syndrome Other: Study voucher card Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11001 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Actual Study Start Date : June 5, 2015
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : October 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: Copayment Intervention Arm
Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
 Other: Study voucher card
Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
No Intervention: Usual Care Arm
For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.


Outcome Measures
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Primary Outcome Measures :
  1. Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events [ Time Frame: 12 months ]
    To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.

  2. Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor [ Time Frame: 12 months ]
    To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.


Secondary Outcome Measures :
  1. P2Y12 Receptor Inhibitor Selection [ Time Frame: 12 months ]
    To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406677


Locations
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Sponsors and Collaborators
AstraZeneca
Duke Clinical Research Institute
Investigators
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Principal Investigator: Tracy Wang, MD, MHS, MSc Duke University
Study Chair: Eric Peterson, MD, MPH, FAHA, FACC Duke University
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] March 12, 2015
Statistical Analysis Plan  [PDF] November 30, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02406677    
Other Study ID Numbers: D5130R00030
First Posted: April 2, 2015    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by AstraZeneca:
Acute Coronary Syndromes, ACS, Myocardial Infarction, STEMI, NSTEMI, MI, Co-Payments, Copay, Cost Sharing
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Infarction
Pathologic Processes
Ischemia
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases