Clinical trial NCT02406677: Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Official title: Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cost Sharing, Acute Coronary Syndrome
Keywords: Acute Coronary Syndromes, ACS, Myocardial Infarction, STEMI, NSTEMI, MI, Co-Payments, Copay, Cost Sharing
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2015-04-02
Enrollment: 11001
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events
timeFrame: 12 months
measure: Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor
timeFrame: 12 months
Secondary outcomes:
measure: P2Y12 Receptor Inhibitor Selection
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
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state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
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city: Anchorage
country: United States
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city: Cottonwood
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state: Arizona
city: Flagstaff
country: United States
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city: Phoenix
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city: Fayetteville
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city: Fort Smith
country: United States
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city: Jonesboro
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state: California
city: Huntington Beach
country: United States
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city: Loma Linda
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city: Los Angeles
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city: Los Angeles
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city: Northridge
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city: Pasadena
country: United States
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city: Riverside
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city: Aurora
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city: Danbury
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city: Boynton Beach
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city: Bradenton
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city: Atlanta
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city: Macon
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city: Marietta
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city: Suwanee
country: United States
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city: Honolulu
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city: Coeur d'Alene
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state: Idaho
city: Aurora
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city: Belleville
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city: Chicago
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city: Boston
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city: Brighton
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city: Ann Arbor
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city: Bay City
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city: Detroit
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city: Detroit
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city: Grand Blanc
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city: Grand Rapids
country: United States
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city: Jackson
country: United States
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city: Marquette
country: United States
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city: Mount Clemens
country: United States
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city: Petoskey
country: United States
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city: Pontiac
country: United States
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state: Michigan
city: Saginaw
country: United States
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city: Saint Joseph
country: United States
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country: United States
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city: Warren
country: United States
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city: Duluth
country: United States
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state: Minnesota
city: Minneapolis
country: United States
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city: Saint Cloud
country: United States
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city: Saint Paul
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city: Saint Paul
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city: Hattiesburg
country: United States
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state: Mississippi
city: Bridgeton
country: United States
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city: Fenton
country: United States
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city: Joplin
country: United States
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city: Kansas City
country: United States
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city: Kansas City
country: United States
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state: Missouri
city: North Kansas City
country: United States
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state: Missouri
city: Saint Charles
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Saint Louis
country: United States
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city: Saint Louis
country: United States
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state: Missouri
city: Saint Louis
country: United States
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city: Saint Louis
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Lincoln
country: United States
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state: Nebraska
city: Lincoln
country: United States
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city: Omaha
country: United States
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state: Nebraska
city: Omaha
country: United States
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city: Omaha
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state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: Reno
country: United States
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state: Nevada
city: Reno
country: United States
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state: Nevada
city: Bridgewater
country: United States
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state: New Jersey
city: Flemington
country: United States
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state: New Jersey
city: Haddon Heights
country: United States
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state: New Jersey
city: Haddon Heights
country: United States
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state: New Jersey
city: Moorestown
country: United States
facility: Research Site
state: New Jersey
city: Newark
country: United States
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state: New Jersey
city: Paterson
country: United States
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state: New Jersey
city: Pomona
country: United States
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state: New Jersey
city: Ridgewood
country: United States
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state: New Jersey
city: Teaneck
country: United States
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state: New Jersey
city: Voorhees
country: United States
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state: New Jersey
city: Albany
country: United States
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state: New York
city: Cooperstown
country: United States
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state: New York
city: Johnson City
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Poughkeepsie
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Schenectady
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Stony Brook
country: United States
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state: New York
city: Utica
country: United States
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city: Valhalla
country: United States
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city: Asheville
country: United States
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state: North Carolina
city: Durham
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city: Gastonia
country: United States
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city: High Point
country: United States
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state: North Carolina
city: Lumberton
country: United States
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city: Morehead City
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state: North Carolina
city: Pinehurst
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Raleigh
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city: Wilmington
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city: Winston-Salem
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state: North Dakota
city: Canton
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city: Cincinnati
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city: Dayton
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city: Portland
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city: Allentown
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city: Camp Hill
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city: Danville
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city: Doylestown
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city: Lancaster
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city: Philadelphia
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city: Pittsburgh
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city: Sayre
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city: Scranton
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city: Sellersville
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city: West Reading
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city: York
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state: Pennsylvania
city: York
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city: Warwick
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state: Rhode Island
city: Anderson
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state: South Carolina
city: Charleston
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state: South Carolina
city: Charleston
country: United States
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state: South Carolina
city: Columbia
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state: South Carolina
city: Columbia
country: United States
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state: South Carolina
city: Greenwood
country: United States
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state: South Carolina
city: West Columbia
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Jackson
country: United States
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state: Tennessee
city: Knoxville
country: United States
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city: Memphis
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city: Memphis
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city: Oak Ridge
country: United States
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state: Tennessee
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: New Braunfels
country: United States
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state: Texas
city: Palestine
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Temple
country: United States
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state: Texas
city: Waco
country: United States
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state: Texas
city: Webster
country: United States
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state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Lynchburg
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Roanoke
country: United States
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state: Virginia
city: Winchester
country: United States
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state: Virginia
city: Puyallup
country: United States
facility: Research Site
state: Washington
city: Renton
country: United States
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state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: La Crosse
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Racine
country: United States
facility: Research Site
state: Wisconsin
city: Waukesha
country: United States
facility: Research Site
state: Wisconsin
city: Caguas
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Duke University
name: Tracy Wang, MD, MHS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Eric Peterson, MD, MPH, FAHA, FACC
role: STUDY_CHAIR
References:
citation: Rymer JA, Kaltenbach LA, Peterson ED, Cohen DJ, Fonarow GC, Choudhry NK, Henry TD, Cannon CP, Wang TY. Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS. J Am Heart Assoc. 2022 Oct 18;11(20):e026421. doi: 10.1161/JAHA.122.026421. Epub 2022 Oct 17.
citation: Fanaroff AC, Peterson ED, Kaltenbach LA, Anstrom KJ, Fonarow GC, Henry TD, Cannon CP, Choudhry NK, Cohen DJ, Atreja N, Bhalla N, Eudicone JM, Wang TY. Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial. Circ Cardiovasc Qual Outcomes. 2020 May;13(5):e006182. doi: 10.1161/CIRCOUTCOMES.119.006182. Epub 2020 May 12.
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