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

NCT ID: NCT02406677

Last Updated: 2019-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-05

Study Completion Date

2017-10-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cost Sharing, Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Study voucher card

Intervention Type OTHER

Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor

Usual Care Arm

For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Study voucher card

Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Clinical Research Institute

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy Wang, MD, MHS, MSc

Role: PRINCIPAL_INVESTIGATOR

Duke University

Eric Peterson, MD, MPH, FAHA, FACC

Role: STUDY_CHAIR

Duke University

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Mobile, Alabama, United States

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Anchorage, Alaska, United States

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Cottonwood, Arizona, United States

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Flagstaff, Arizona, United States

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Phoenix, Arizona, United States

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Fayetteville, Arkansas, United States

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Fort Smith, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Escondido, California, United States

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Huntington Beach, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Pasadena, California, United States

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Riverside, California, United States

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Salinas, California, United States

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Stockton, California, United States

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Thousand Oaks, California, United States

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Torrance, California, United States

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Vista, California, United States

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Aurora, Colorado, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Bridgeport, Connecticut, United States

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Danbury, Connecticut, United States

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New Haven, Connecticut, United States

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Stamford, Connecticut, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Bradenton, Florida, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Hudson, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville Beach, Florida, United States

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Lakeland, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Panama City, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Cumming, Georgia, United States

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Lawrenceville, Georgia, United States

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Macon, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Suwanee, Georgia, United States

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Honolulu, Hawaii, United States

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Coeur d'Alene, Idaho, United States

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Belleville, Illinois, United States

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Joliet, Illinois, United States

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Peoria, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Urbana, Illinois, United States

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Bloomington, Indiana, United States

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Englewood, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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Richmond, Indiana, United States

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South Bend, Indiana, United States

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Valparaiso, Indiana, United States

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Davenport, Iowa, United States

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Iowa City, Iowa, United States

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West Des Moines, Iowa, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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Bossier City, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Rockport, Maine, United States

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Clinton, Maryland, United States

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Salisbury, Maryland, United States

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Brighton, Massachusetts, United States

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Hyannis, Massachusetts, United States

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Worcester, Massachusetts, United States

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Alpena, Michigan, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Marquette, Michigan, United States

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Mount Clemens, Michigan, United States

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Petoskey, Michigan, United States

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Pontiac, Michigan, United States

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Saginaw, Michigan, United States

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Saint Joseph, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Saint Paul, Minnesota, United States

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Saint Paul, Minnesota, United States

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Hattiesburg, Mississippi, United States

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Bridgeton, Missouri, United States

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Fenton, Missouri, United States

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Joplin, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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North Kansas City, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Reno, Nevada, United States

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Bridgewater, New Jersey, United States

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Flemington, New Jersey, United States

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Haddon Heights, New Jersey, United States

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Haddon Heights, New Jersey, United States

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Moorestown, New Jersey, United States

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Newark, New Jersey, United States

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Paterson, New Jersey, United States

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Pomona, New Jersey, United States

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Ridgewood, New Jersey, United States

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Teaneck, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albany, New York, United States

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Cooperstown, New York, United States

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Johnson City, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Rochester, New York, United States

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Schenectady, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Utica, New York, United States

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Valhalla, New York, United States

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Asheville, North Carolina, United States

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Durham, North Carolina, United States

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Gastonia, North Carolina, United States

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High Point, North Carolina, United States

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Lumberton, North Carolina, United States

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Morehead City, North Carolina, United States

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Pinehurst, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Grand Forks, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Middleburg Heights, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Bend, Oregon, United States

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Portland, Oregon, United States

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Tualatin, Oregon, United States

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Abington, Pennsylvania, United States

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Allentown, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Chambersburg, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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York, Pennsylvania, United States

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York, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Columbia, South Carolina, United States

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Greenwood, South Carolina, United States

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West Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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New Braunfels, Texas, United States

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Palestine, Texas, United States

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Plano, Texas, United States

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Round Rock, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Waco, Texas, United States

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Webster, Texas, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Lynchburg, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Roanoke, Virginia, United States

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Winchester, Virginia, United States

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Puyallup, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Green Bay, Wisconsin, United States

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La Crosse, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Racine, Wisconsin, United States

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Waukesha, Wisconsin, United States

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Caguas, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Rymer JA, Wegermann ZK, Kaltenbach LA, Webb LE, Peterson ED, Wang TY. Challenge in Predicting Persistence to P2Y12 Inhibitors: A Perspective From the ARTEMIS Trial. J Am Heart Assoc. 2023 Jun 20;12(12):e029063. doi: 10.1161/JAHA.122.029063. Epub 2023 Jun 10.

Reference Type DERIVED
PMID: 37301758 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36250667 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32393129 (View on PubMed)

Doll JA, Kaltenbach LA, Anstrom KJ, Cannon CP, Henry TD, Fonarow GC, Choudhry NK, Fonseca E, Bhalla N, Eudicone JM, Peterson ED, Wang TY. Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs. J Am Heart Assoc. 2020 Apr 21;9(8):e014975. doi: 10.1161/JAHA.119.014975. Epub 2020 Apr 17.

Reference Type DERIVED
PMID: 32299284 (View on PubMed)

Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, Choudhry NK, Henry TD, Anstrom KJ, Cohen DJ, Fonseca E, Khan ND, Fonarow GC, Wang TY. Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial. JAMA Cardiol. 2020 May 1;5(5):532-539. doi: 10.1001/jamacardio.2020.0125.

Reference Type DERIVED
PMID: 32129795 (View on PubMed)

Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, Choudhry NK, Henry TD, Anstrom KJ, Cohen DJ, Fonseca E, Khan ND, Fonarow GC, Wang TY. Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):38-46. doi: 10.1001/jamacardio.2019.4408.

Reference Type DERIVED
PMID: 31721978 (View on PubMed)

Wang TY, Kaltenbach LA, Cannon CP, Fonarow GC, Choudhry NK, Henry TD, Cohen DJ, Bhandary D, Khan ND, Anstrom KJ, Peterson ED. Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. JAMA. 2019 Jan 1;321(1):44-55. doi: 10.1001/jama.2018.19791.

Reference Type DERIVED
PMID: 30620370 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3805&filename=ARTEMIS%20D5130R00030_Protocol_03.12.2015%20REDACTED%20PDF.A.pdf

D5130R00030\_CSP\_redacted

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3805&filename=ARTEMIS_D5130R00030_SAP_Final_2017.11.30_signed_Redacted.PDF.A.pdf

D5130R00030\_SAP\_Redacted

Other Identifiers

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D5130R00030

Identifier Type: -

Identifier Source: org_study_id

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CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)
NCT02806102 UNKNOWN
Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
NCT00136929 UNKNOWN NA
3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI
NCT04570345 UNKNOWN PHASE4
A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies
NCT00566774 COMPLETED PHASE4
Effect of Classic Secondary Prevention in Type 2 MI: A Target Trial Emulation Study
NCT06736353 COMPLETED
Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
NCT02219802 UNKNOWN NA
Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI
NCT04688723 UNKNOWN PHASE4
Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes
NCT06851325 COMPLETED
CARESS in Acute Myocardial Infarction
NCT00220571 COMPLETED PHASE3
Phase III Acute Coronary Syndrome
NCT00831441 TERMINATED PHASE3
Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients
NCT02942550 COMPLETED PHASE4
Antithrombotic Strategy for AF Patients With High Risk CAD
NCT06866665 NOT_YET_RECRUITING NA
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
NCT01000727 COMPLETED PHASE3
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction
NCT03991143 COMPLETED PHASE2
PROTECT-TIMI 30 Trial
NCT00250471 COMPLETED PHASE3
Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)
NCT00091637 COMPLETED PHASE3
DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization
NCT02146664 WITHDRAWN PHASE2/PHASE3
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
NCT02931045 COMPLETED PHASE4
Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor
NCT02422888 UNKNOWN PHASE4
Prevention of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant (EARLYmyo-LVT Ⅱ)
NCT03786757 UNKNOWN PHASE3
Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept
NCT03312855 COMPLETED PHASE2
A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)
NCT02235389 TERMINATED
Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine
NCT02403830 COMPLETED PHASE4
Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients
NCT03087539 UNKNOWN PHASE2