Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS)
2019년 9월 30일 업데이트: AstraZeneca
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
11001
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
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Huntsville, Alabama, 미국, 35613
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Mobile, Alabama, 미국, 36608
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Mobile, Alabama, 미국, 36617
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Alaska
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Anchorage, Alaska, 미국, 99508
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Arizona
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Cottonwood, Arizona, 미국, 86326
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Flagstaff, Arizona, 미국, 86001
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Phoenix, Arizona, 미국, 85008
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
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Fort Smith, Arkansas, 미국, 72901
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Jonesboro, Arkansas, 미국, 72401
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Little Rock, Arkansas, 미국, 72211
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California
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Escondido, California, 미국, 92025
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Huntington Beach, California, 미국, 92648
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Loma Linda, California, 미국, 92354
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Los Angeles, California, 미국, 90048
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Los Angeles, California, 미국, 90095
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Northridge, California, 미국, 91328
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Pasadena, California, 미국, 91105
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Riverside, California, 미국, 92501
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Salinas, California, 미국, 93901
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Stockton, California, 미국, 95210
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Thousand Oaks, California, 미국, 91360
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Torrance, California, 미국, 90505-5073
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Vista, California, 미국, 92083
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Colorado
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Aurora, Colorado, 미국, 80045
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Aurora, Colorado, 미국, 80012
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Colorado Springs, Colorado, 미국, 80907
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Denver, Colorado, 미국, 80204
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Connecticut
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Bridgeport, Connecticut, 미국, 06610
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Danbury, Connecticut, 미국, 6810
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New Haven, Connecticut, 미국, 06519
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Stamford, Connecticut, 미국, 06904
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Florida
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Boynton Beach, Florida, 미국, 33435
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Bradenton, Florida, 미국, 34205
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Bradenton, Florida, 미국, 34209
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Daytona Beach, Florida, 미국, 32114
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Gainesville, Florida, 미국, 32607
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Hollywood, Florida, 미국, 33021
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Hudson, Florida, 미국, 34667
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Jacksonville, Florida, 미국, 32207
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Jacksonville, Florida, 미국, 32204
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Jacksonville, Florida, 미국, 32216
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Jacksonville, Florida, 미국, 32258
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Jacksonville Beach, Florida, 미국, 32250
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Lakeland, Florida, 미국, 33805
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Largo, Florida, 미국, 33770
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Miami, Florida, 미국, 33133
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Ocala, Florida, 미국, 34474
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Orlando, Florida, 미국, 32803
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Panama City, Florida, 미국, 32401
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Pensacola, Florida, 미국, 32501
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Pensacola, Florida, 미국, 32504
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Safety Harbor, Florida, 미국, 34695
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Saint Petersburg, Florida, 미국, 33713
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Saint Petersburg, Florida, 미국, 33709
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Saint Petersburg, Florida, 미국, 33701
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Sarasota, Florida, 미국, 34239
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Tallahassee, Florida, 미국, 32308
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Tampa, Florida, 미국, 33607
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Tampa, Florida, 미국, 33613
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Winter Haven, Florida, 미국, 33881
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Georgia
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Athens, Georgia, 미국, 30606
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Atlanta, Georgia, 미국, 30342
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Atlanta, Georgia, 미국, 30303
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Augusta, Georgia, 미국, 30912
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Cumming, Georgia, 미국, 30041
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Lawrenceville, Georgia, 미국, 30045
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Macon, Georgia, 미국, 31217
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Macon, Georgia, 미국, 31210
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Marietta, Georgia, 미국, 30060
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Suwanee, Georgia, 미국, 30024
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Hawaii
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Honolulu, Hawaii, 미국, 96813
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Idaho
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Coeur d'Alene, Idaho, 미국, 83814
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Illinois
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Aurora, Illinois, 미국, 60504
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Belleville, Illinois, 미국, 62226
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Chicago, Illinois, 미국, 60612
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Chicago, Illinois, 미국, 60637
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Joliet, Illinois, 미국, 60435
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Peoria, Illinois, 미국, 61614
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Rockford, Illinois, 미국, 61107
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Rockford, Illinois, 미국, 61103
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Springfield, Illinois, 미국, 62701
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Urbana, Illinois, 미국, 51801
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Indiana
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Bloomington, Indiana, 미국, 47403
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Englewood, Indiana, 미국, 7631
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Indianapolis, Indiana, 미국, 46237
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Indianapolis, Indiana, 미국, 46250
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Indianapolis, Indiana, 미국, 46290
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Muncie, Indiana, 미국, 47303
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Munster, Indiana, 미국, 46321
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Richmond, Indiana, 미국, 47375
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South Bend, Indiana, 미국, 46601
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Valparaiso, Indiana, 미국, 46383
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Iowa
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Davenport, Iowa, 미국, 52803
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Iowa City, Iowa, 미국, 52242
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West Des Moines, Iowa, 미국, 50266
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Kansas
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Overland Park, Kansas, 미국, 66209
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Kentucky
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Lexington, Kentucky, 미국, 40503
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Louisville, Kentucky, 미국, 40202
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Louisville, Kentucky, 미국, 40205
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Louisville, Kentucky, 미국, 40292
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Louisiana
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Alexandria, Louisiana, 미국, 71301
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Bossier City, Louisiana, 미국, 71111
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New Orleans, Louisiana, 미국, 70121
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Shreveport, Louisiana, 미국, 71103
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Maine
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Rockport, Maine, 미국, 04856
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Maryland
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Annapolis, Maryland, 미국, 21401
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Baltimore, Maryland, 미국, 21229
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Baltimore, Maryland, 미국, 21215
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Bethesda, Maryland, 미국, 20814
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Clinton, Maryland, 미국, 20735
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Columbia, Maryland, 미국, 21044
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Rockville, Maryland, 미국, 20850
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Salisbury, Maryland, 미국, 21804
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Massachusetts
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Boston, Massachusetts, 미국, 2215
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Boston, Massachusetts, 미국, 02118
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Brighton, Massachusetts, 미국, 2135
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Hyannis, Massachusetts, 미국, 02601
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Worcester, Massachusetts, 미국, 1655
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Michigan
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Alpena, Michigan, 미국, 49707
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Ann Arbor, Michigan, 미국, 48109
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Bay City, Michigan, 미국, 48708
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Detroit, Michigan, 미국, 48202
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Detroit, Michigan, 미국, 48236
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Flint, Michigan, 미국, 48532
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Grand Blanc, Michigan, 미국, 48439
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Grand Rapids, Michigan, 미국, 49503
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Jackson, Michigan, 미국, 39216
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Marquette, Michigan, 미국, 49855
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Mount Clemens, Michigan, 미국, 48043
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Petoskey, Michigan, 미국, 49770
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Pontiac, Michigan, 미국, 48341
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Saginaw, Michigan, 미국, 48602
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Saint Joseph, Michigan, 미국, 49085
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Southfield, Michigan, 미국, 48075
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Warren, Michigan, 미국, 48093
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Minnesota
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Duluth, Minnesota, 미국, 55805
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Minneapolis, Minnesota, 미국, 55407
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Saint Cloud, Minnesota, 미국, 56303
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Saint Paul, Minnesota, 미국, 55101
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Saint Paul, Minnesota, 미국, 55102
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Mississippi
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Hattiesburg, Mississippi, 미국, 39401
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Missouri
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Bridgeton, Missouri, 미국, 63044
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Fenton, Missouri, 미국, 63026
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Joplin, Missouri, 미국, 64804
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Kansas City, Missouri, 미국, 64114
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Kansas City, Missouri, 미국, 64111
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North Kansas City, Missouri, 미국, 64116
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Saint Charles, Missouri, 미국, 63301
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Saint Louis, Missouri, 미국, 63110
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Saint Louis, Missouri, 미국, 63136
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Saint Louis, Missouri, 미국, 63117
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Saint Louis, Missouri, 미국, 63128
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Saint Louis, Missouri, 미국, 63131-2374
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Saint Louis, Missouri, 미국, 63367
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Montana
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Billings, Montana, 미국, 59101
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Nebraska
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Lincoln, Nebraska, 미국, 68506
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Lincoln, Nebraska, 미국, 68526
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Omaha, Nebraska, 미국, 68131
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Omaha, Nebraska, 미국, 68105
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Omaha, Nebraska, 미국, 68154
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Nevada
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Las Vegas, Nevada, 미국, 89128
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Reno, Nevada, 미국, 89502
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Reno, Nevada, 미국, 89503
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New Jersey
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Bridgewater, New Jersey, 미국, 08807
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Flemington, New Jersey, 미국, 08822
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Haddon Heights, New Jersey, 미국, 08035
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Haddon Heights, New Jersey, 미국, 8035
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Moorestown, New Jersey, 미국, 08057
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Newark, New Jersey, 미국, 07102
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Paterson, New Jersey, 미국, 07503
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Pomona, New Jersey, 미국, 08240
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Ridgewood, New Jersey, 미국, 07450
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Teaneck, New Jersey, 미국, 07666
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Voorhees, New Jersey, 미국, 08043
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New York
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Albany, New York, 미국, 12205
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Cooperstown, New York, 미국, 13326
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Johnson City, New York, 미국, 13790
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New York, New York, 미국, 10029
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Poughkeepsie, New York, 미국, 12601
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Rochester, New York, 미국, 14621-3001
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Schenectady, New York, 미국, 12308
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Staten Island, New York, 미국, 10310
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Stony Brook, New York, 미국, 11794
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Utica, New York, 미국, 13501
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Valhalla, New York, 미국, 10595
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North Carolina
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Asheville, North Carolina, 미국, 28803
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Durham, North Carolina, 미국, 27710
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Gastonia, North Carolina, 미국, 28054
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High Point, North Carolina, 미국, 27262
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Lumberton, North Carolina, 미국, 28358
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Morehead City, North Carolina, 미국, 28557
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Pinehurst, North Carolina, 미국, 28374
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Raleigh, North Carolina, 미국, 27607
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Raleigh, North Carolina, 미국, 27610
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Wilmington, North Carolina, 미국, 28403
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Winston-Salem, North Carolina, 미국, 27104
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North Dakota
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Grand Forks, North Dakota, 미국, 58201
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Ohio
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Canton, Ohio, 미국, 447018
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Cincinnati, Ohio, 미국, 45267
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Cleveland, Ohio, 미국, 44106
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Dayton, Ohio, 미국, 45406
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Kettering, Ohio, 미국, 45429
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Middleburg Heights, Ohio, 미국, 44130
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Toledo, Ohio, 미국, 43615
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
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Oklahoma City, Oklahoma, 미국, 73120
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Oregon
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Bend, Oregon, 미국, 97701
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Portland, Oregon, 미국, 97062
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Tualatin, Oregon, 미국, 97062
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Pennsylvania
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Abington, Pennsylvania, 미국, 19001
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Allentown, Pennsylvania, 미국, 18103
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Camp Hill, Pennsylvania, 미국, 17011
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Chambersburg, Pennsylvania, 미국, 17201
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Danville, Pennsylvania, 미국, 17822
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Doylestown, Pennsylvania, 미국, 18901
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Lancaster, Pennsylvania, 미국, 17603
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Philadelphia, Pennsylvania, 미국, 19102
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Pittsburgh, Pennsylvania, 미국, 15212
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Pittsburgh, Pennsylvania, 미국, 15232
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Sayre, Pennsylvania, 미국, 18840
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Scranton, Pennsylvania, 미국, 18508
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Sellersville, Pennsylvania, 미국, 18960
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West Reading, Pennsylvania, 미국, 19611
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Wilkes-Barre, Pennsylvania, 미국, 18711
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York, Pennsylvania, 미국, 17403
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York, Pennsylvania, 미국, 17405
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Rhode Island
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Warwick, Rhode Island, 미국, 02886
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South Carolina
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Anderson, South Carolina, 미국, 29621
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Charleston, South Carolina, 미국, 29425
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Charleston, South Carolina, 미국, 29401
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Columbia, South Carolina, 미국, 29204
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Columbia, South Carolina, 미국, 29203
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Greenwood, South Carolina, 미국, 29646
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West Columbia, South Carolina, 미국, 29169
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South Dakota
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Rapid City, South Dakota, 미국, 57701
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Tennessee
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Jackson, Tennessee, 미국, 38301
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Knoxville, Tennessee, 미국, 37934
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Memphis, Tennessee, 미국, 38120
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Memphis, Tennessee, 미국, 38104
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Oak Ridge, Tennessee, 미국, 37830
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Texas
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Dallas, Texas, 미국, 75231
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Houston, Texas, 미국, 77030
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Houston, Texas, 미국, 77074
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New Braunfels, Texas, 미국, 78130
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Palestine, Texas, 미국, 75801
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Plano, Texas, 미국, 75093
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Round Rock, Texas, 미국, 78665
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San Antonio, Texas, 미국, 78201
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Temple, Texas, 미국, 76508
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Waco, Texas, 미국, 76712
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Webster, Texas, 미국, 77598
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Vermont
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Burlington, Vermont, 미국, 05401
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Virginia
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Charlottesville, Virginia, 미국, 22908
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Lynchburg, Virginia, 미국, 24501
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Norfolk, Virginia, 미국, 23507
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Richmond, Virginia, 미국, 23229
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Roanoke, Virginia, 미국, 24014
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Winchester, Virginia, 미국, 22601
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Washington
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Puyallup, Washington, 미국, 98372
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Renton, Washington, 미국, 98055
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Spokane, Washington, 미국, 99204
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West Virginia
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Morgantown, West Virginia, 미국, 26505
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Wisconsin
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Green Bay, Wisconsin, 미국, 54301
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La Crosse, Wisconsin, 미국, 54601
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Milwaukee, Wisconsin, 미국, 53226
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Milwaukee, Wisconsin, 미국, 53215
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Milwaukee, Wisconsin, 미국, 53211
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Racine, Wisconsin, 미국, 53405
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Waukesha, Wisconsin, 미국, 53188
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Caguas, 푸에르토 리코, 00725
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
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간섭 없음: Usual Care Arm
For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events
기간: 12 months
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To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.
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12 months
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Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor
기간: 12 months
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To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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P2Y12 Receptor Inhibitor Selection
기간: 12 months
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To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.
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12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Tracy Wang, MD, MHS, MSc, Duke University
- 연구 의자: Eric Peterson, MD, MPH, FAHA, FACC, Duke University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 6월 5일
기본 완료 (실제)
2017년 10월 23일
연구 완료 (실제)
2017년 10월 23일
연구 등록 날짜
최초 제출
2015년 3월 30일
QC 기준을 충족하는 최초 제출
2015년 4월 1일
처음 게시됨 (추정)
2015년 4월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 30일
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .