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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copayment Intervention Arm | Experimental | 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. |
|
| Usual Care Arm | No Intervention | For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study voucher card | Other | Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events | To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge. | 12 months |
| Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor | To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| P2Y12 Receptor Inhibitor Selection | To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge. | 12 months |
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Inclusion Criteria:
Patients are eligible to be included in the study if they meet all of the following criteria:
Exclusion Criteria:
Patients are excluded if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Wang, MD, MHS, MSc | Duke University | Principal Investigator |
| Eric Peterson, MD, MPH, FAHA, FACC | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37301758 | Derived | 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. | |
| 36250667 | Derived | 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. |
| Label | URL |
|---|---|
| D5130R00030\_CSP\_redacted | View source |
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The study population included patients STEMI or NSTEMI who were treated with a P2Y12 receptor inhibitor. After patient enrollment into hospitals, each hospital was randomized into either the intervention or the control arm (cluster randomization). The randomization scheme was changed from 1:1 to 2:1 mid-study. 12 month study duration.
Study recruited patients on P2Y12 inhibitor therapy with US-based health insurance. Recruitment into 301 study sites (hospitals) in the US was conducted from June, 2015 to September, 2016. The study evaluated whether patient copayment reduction significantly influenced antiplatelet therapy selection and long-term adherence.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care Arm |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2015 | Oct 18, 2018 |
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| Huntsville |
| Alabama |
| 35613 |
| United States |
| Research Site | Mobile | Alabama | 36608 | United States |
| Research Site | Mobile | Alabama | 36617 | United States |
| Research Site | Anchorage | Alaska | 99508 | United States |
| Research Site | Cottonwood | Arizona | 86326 | United States |
| Research Site | Flagstaff | Arizona | 86001 | United States |
| Research Site | Phoenix | Arizona | 85008 | United States |
| Research Site | Fayetteville | Arkansas | 72703 | United States |
| Research Site | Fort Smith | Arkansas | 72901 | United States |
| Research Site | Jonesboro | Arkansas | 72401 | United States |
| Research Site | Little Rock | Arkansas | 72211 | United States |
| Research Site | Escondido | California | 92025 | United States |
| Research Site | Huntington Beach | California | 92648 | United States |
| Research Site | Loma Linda | California | 92354 | United States |
| Research Site | Los Angeles | California | 90048 | United States |
| Research Site | Los Angeles | California | 90095 | United States |
| Research Site | Northridge | California | 91328 | United States |
| Research Site | Pasadena | California | 91105 | United States |
| Research Site | Riverside | California | 92501 | United States |
| Research Site | Salinas | California | 93901 | United States |
| Research Site | Stockton | California | 95210 | United States |
| Research Site | Thousand Oaks | California | 91360 | United States |
| Research Site | Torrance | California | 90505-5073 | United States |
| Research Site | Vista | California | 92083 | United States |
| Research Site | Aurora | Colorado | 80012 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Research Site | Denver | Colorado | 80204 | United States |
| Research Site | Bridgeport | Connecticut | 06610 | United States |
| Research Site | Danbury | Connecticut | 6810 | United States |
| Research Site | New Haven | Connecticut | 06519 | United States |
| Research Site | Stamford | Connecticut | 06904 | United States |
| Research Site | Boynton Beach | Florida | 33435 | United States |
| Research Site | Bradenton | Florida | 34205 | United States |
| Research Site | Bradenton | Florida | 34209 | United States |
| Research Site | Daytona Beach | Florida | 32114 | United States |
| Research Site | Gainesville | Florida | 32607 | United States |
| Research Site | Hollywood | Florida | 33021 | United States |
| Research Site | Hudson | Florida | 34667 | United States |
| Research Site | Jacksonville | Florida | 32204 | United States |
| Research Site | Jacksonville | Florida | 32207 | United States |
| Research Site | Jacksonville | Florida | 32216 | United States |
| Research Site | Jacksonville | Florida | 32258 | United States |
| Research Site | Jacksonville Beach | Florida | 32250 | United States |
| Research Site | Lakeland | Florida | 33805 | United States |
| Research Site | Largo | Florida | 33770 | United States |
| Research Site | Miami | Florida | 33133 | United States |
| Research Site | Ocala | Florida | 34474 | United States |
| Research Site | Orlando | Florida | 32803 | United States |
| Research Site | Panama City | Florida | 32401 | United States |
| Research Site | Pensacola | Florida | 32501 | United States |
| Research Site | Pensacola | Florida | 32504 | United States |
| Research Site | Safety Harbor | Florida | 34695 | United States |
| Research Site | Sarasota | Florida | 34239 | United States |
| Research Site | St. Petersburg | Florida | 33701 | United States |
| Research Site | St. Petersburg | Florida | 33709 | United States |
| Research Site | St. Petersburg | Florida | 33713 | United States |
| Research Site | Tallahassee | Florida | 32308 | United States |
| Research Site | Tampa | Florida | 33607 | United States |
| Research Site | Tampa | Florida | 33613 | United States |
| Research Site | Winter Haven | Florida | 33881 | United States |
| Research Site | Athens | Georgia | 30606 | United States |
| Research Site | Atlanta | Georgia | 30303 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Augusta | Georgia | 30912 | United States |
| Research Site | Cumming | Georgia | 30041 | United States |
| Research Site | Lawrenceville | Georgia | 30045 | United States |
| Research Site | Macon | Georgia | 31210 | United States |
| Research Site | Macon | Georgia | 31217 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Suwanee | Georgia | 30024 | United States |
| Research Site | Honolulu | Hawaii | 96813 | United States |
| Research Site | Coeur d'Alene | Idaho | 83814 | United States |
| Research Site | Aurora | Illinois | 60504 | United States |
| Research Site | Belleville | Illinois | 62226 | United States |
| Research Site | Chicago | Illinois | 60612 | United States |
| Research Site | Chicago | Illinois | 60637 | United States |
| Research Site | Joliet | Illinois | 60435 | United States |
| Research Site | Peoria | Illinois | 61614 | United States |
| Research Site | Rockford | Illinois | 61103 | United States |
| Research Site | Rockford | Illinois | 61107 | United States |
| Research Site | Springfield | Illinois | 62701 | United States |
| Research Site | Urbana | Illinois | 51801 | United States |
| Research Site | Bloomington | Indiana | 47403 | United States |
| Research Site | Englewood | Indiana | 7631 | United States |
| Research Site | Indianapolis | Indiana | 46237 | United States |
| Research Site | Indianapolis | Indiana | 46250 | United States |
| Research Site | Indianapolis | Indiana | 46290 | United States |
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| Research Site | Munster | Indiana | 46321 | United States |
| Research Site | Richmond | Indiana | 47375 | United States |
| Research Site | South Bend | Indiana | 46601 | United States |
| Research Site | Valparaiso | Indiana | 46383 | United States |
| Research Site | Davenport | Iowa | 52803 | United States |
| Research Site | Iowa City | Iowa | 52242 | United States |
| Research Site | West Des Moines | Iowa | 50266 | United States |
| Research Site | Overland Park | Kansas | 66209 | United States |
| Research Site | Lexington | Kentucky | 40503 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Louisville | Kentucky | 40205 | United States |
| Research Site | Louisville | Kentucky | 40292 | United States |
| Research Site | Alexandria | Louisiana | 71301 | United States |
| Research Site | Bossier City | Louisiana | 71111 | United States |
| Research Site | New Orleans | Louisiana | 70121 | United States |
| Research Site | Shreveport | Louisiana | 71103 | United States |
| Research Site | Rockport | Maine | 04856 | United States |
| Research Site | Annapolis | Maryland | 21401 | United States |
| Research Site | Baltimore | Maryland | 21215 | United States |
| Research Site | Baltimore | Maryland | 21229 | United States |
| Research Site | Bethesda | Maryland | 20814 | United States |
| Research Site | Clinton | Maryland | 20735 | United States |
| Research Site | Columbia | Maryland | 21044 | United States |
| Research Site | Rockville | Maryland | 20850 | United States |
| Research Site | Salisbury | Maryland | 21804 | United States |
| Research Site | Boston | Massachusetts | 02118 | United States |
| Research Site | Boston | Massachusetts | 2215 | United States |
| Research Site | Brighton | Massachusetts | 2135 | United States |
| Research Site | Hyannis | Massachusetts | 02601 | United States |
| Research Site | Worcester | Massachusetts | 1655 | United States |
| Research Site | Alpena | Michigan | 49707 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Bay City | Michigan | 48708 | United States |
| Research Site | Detroit | Michigan | 48202 | United States |
| Research Site | Detroit | Michigan | 48236 | United States |
| Research Site | Flint | Michigan | 48532 | United States |
| Research Site | Grand Blanc | Michigan | 48439 | United States |
| Research Site | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Jackson | Michigan | 39216 | United States |
| Research Site | Marquette | Michigan | 49855 | United States |
| Research Site | Mount Clemens | Michigan | 48043 | United States |
| Research Site | Petoskey | Michigan | 49770 | United States |
| Research Site | Pontiac | Michigan | 48341 | United States |
| Research Site | Saginaw | Michigan | 48602 | United States |
| Research Site | Saint Joseph | Michigan | 49085 | United States |
| Research Site | Southfield | Michigan | 48075 | United States |
| Research Site | Warren | Michigan | 48093 | United States |
| Research Site | Duluth | Minnesota | 55805 | United States |
| Research Site | Minneapolis | Minnesota | 55407 | United States |
| Research Site | Saint Cloud | Minnesota | 56303 | United States |
| Research Site | Saint Paul | Minnesota | 55101 | United States |
| Research Site | Saint Paul | Minnesota | 55102 | United States |
| Research Site | Hattiesburg | Mississippi | 39401 | United States |
| Research Site | Bridgeton | Missouri | 63044 | United States |
| Research Site | Fenton | Missouri | 63026 | United States |
| Research Site | Joplin | Missouri | 64804 | United States |
| Research Site | Kansas City | Missouri | 64111 | United States |
| Research Site | Kansas City | Missouri | 64114 | United States |
| Research Site | North Kansas City | Missouri | 64116 | United States |
| Research Site | Saint Charles | Missouri | 63301 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | St Louis | Missouri | 63117 | United States |
| Research Site | St Louis | Missouri | 63128 | United States |
| Research Site | St Louis | Missouri | 63131-2374 | United States |
| Research Site | St Louis | Missouri | 63136 | United States |
| Research Site | St Louis | Missouri | 63367 | United States |
| Research Site | Billings | Montana | 59101 | United States |
| Research Site | Lincoln | Nebraska | 68506 | United States |
| Research Site | Lincoln | Nebraska | 68526 | United States |
| Research Site | Omaha | Nebraska | 68105 | United States |
| Research Site | Omaha | Nebraska | 68131 | United States |
| Research Site | Omaha | Nebraska | 68154 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | Reno | Nevada | 89502 | United States |
| Research Site | Reno | Nevada | 89503 | United States |
| Research Site | Bridgewater | New Jersey | 08807 | United States |
| Research Site | Flemington | New Jersey | 08822 | United States |
| Research Site | Haddon Heights | New Jersey | 08035 | United States |
| Research Site | Haddon Heights | New Jersey | 8035 | United States |
| Research Site | Moorestown | New Jersey | 08057 | United States |
| Research Site | Newark | New Jersey | 07102 | United States |
| Research Site | Paterson | New Jersey | 07503 | United States |
| Research Site | Pomona | New Jersey | 08240 | United States |
| Research Site | Ridgewood | New Jersey | 07450 | United States |
| Research Site | Teaneck | New Jersey | 07666 | United States |
| Research Site | Voorhees Township | New Jersey | 08043 | United States |
| Research Site | Albany | New York | 12205 | United States |
| Research Site | Cooperstown | New York | 13326 | United States |
| Research Site | Johnson City | New York | 13790 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Poughkeepsie | New York | 12601 | United States |
| Research Site | Rochester | New York | 14621-3001 | United States |
| Research Site | Schenectady | New York | 12308 | United States |
| Research Site | Staten Island | New York | 10310 | United States |
| Research Site | Stony Brook | New York | 11794 | United States |
| Research Site | Utica | New York | 13501 | United States |
| Research Site | Valhalla | New York | 10595 | United States |
| Research Site | Asheville | North Carolina | 28803 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Gastonia | North Carolina | 28054 | United States |
| Research Site | High Point | North Carolina | 27262 | United States |
| Research Site | Lumberton | North Carolina | 28358 | United States |
| Research Site | Morehead City | North Carolina | 28557 | United States |
| Research Site | Pinehurst | North Carolina | 28374 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Raleigh | North Carolina | 27610 | United States |
| Research Site | Wilmington | North Carolina | 28403 | United States |
| Research Site | Winston-Salem | North Carolina | 27104 | United States |
| Research Site | Grand Forks | North Dakota | 58201 | United States |
| Research Site | Canton | Ohio | 447018 | United States |
| Research Site | Cincinnati | Ohio | 45267 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Dayton | Ohio | 45406 | United States |
| Research Site | Kettering | Ohio | 45429 | United States |
| Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Research Site | Toledo | Ohio | 43615 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | Bend | Oregon | 97701 | United States |
| Research Site | Portland | Oregon | 97062 | United States |
| Research Site | Tualatin | Oregon | 97062 | United States |
| Research Site | Abington | Pennsylvania | 19001 | United States |
| Research Site | Allentown | Pennsylvania | 18103 | United States |
| Research Site | Camp Hill | Pennsylvania | 17011 | United States |
| Research Site | Chambersburg | Pennsylvania | 17201 | United States |
| Research Site | Danville | Pennsylvania | 17822 | United States |
| Research Site | Doylestown | Pennsylvania | 18901 | United States |
| Research Site | Lancaster | Pennsylvania | 17603 | United States |
| Research Site | Philadelphia | Pennsylvania | 19102 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Research Site | Sayre | Pennsylvania | 18840 | United States |
| Research Site | Scranton | Pennsylvania | 18508 | United States |
| Research Site | Sellersville | Pennsylvania | 18960 | United States |
| Research Site | West Reading | Pennsylvania | 19611 | United States |
| Research Site | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Research Site | York | Pennsylvania | 17403 | United States |
| Research Site | York | Pennsylvania | 17405 | United States |
| Research Site | Warwick | Rhode Island | 02886 | United States |
| Research Site | Anderson | South Carolina | 29621 | United States |
| Research Site | Charleston | South Carolina | 29401 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Columbia | South Carolina | 29203 | United States |
| Research Site | Columbia | South Carolina | 29204 | United States |
| Research Site | Greenwood | South Carolina | 29646 | United States |
| Research Site | West Columbia | South Carolina | 29169 | United States |
| Research Site | Rapid City | South Dakota | 57701 | United States |
| Research Site | Jackson | Tennessee | 38301 | United States |
| Research Site | Knoxville | Tennessee | 37934 | United States |
| Research Site | Memphis | Tennessee | 38104 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| Research Site | Oak Ridge | Tennessee | 37830 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | New Braunfels | Texas | 78130 | United States |
| Research Site | Palestine | Texas | 75801 | United States |
| Research Site | Plano | Texas | 75093 | United States |
| Research Site | Round Rock | Texas | 78665 | United States |
| Research Site | San Antonio | Texas | 78201 | United States |
| Research Site | Temple | Texas | 76508 | United States |
| Research Site | Waco | Texas | 76712 | United States |
| Research Site | Webster | Texas | 77598 | United States |
| Research Site | Burlington | Vermont | 05401 | United States |
| Research Site | Charlottesville | Virginia | 22908 | United States |
| Research Site | Lynchburg | Virginia | 24501 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Richmond | Virginia | 23229 | United States |
| Research Site | Roanoke | Virginia | 24014 | United States |
| Research Site | Winchester | Virginia | 22601 | United States |
| Research Site | Puyallup | Washington | 98372 | United States |
| Research Site | Renton | Washington | 98055 | United States |
| Research Site | Spokane | Washington | 99204 | United States |
| Research Site | Morgantown | West Virginia | 26505 | United States |
| Research Site | Green Bay | Wisconsin | 54301 | United States |
| Research Site | La Crosse | Wisconsin | 54601 | United States |
| Research Site | Milwaukee | Wisconsin | 53211 | United States |
| Research Site | Milwaukee | Wisconsin | 53215 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | Racine | Wisconsin | 53405 | United States |
| Research Site | Waukesha | Wisconsin | 53188 | United States |
| Research Site | Caguas | 00725 | Puerto Rico |
| 32393129 | Derived | 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. |
| 32299284 | Derived | 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. |
| 32129795 | Derived | 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. |
| 31721978 | Derived | 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. |
| 30620370 | Derived | 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. |
| D5130R00030\_SAP\_Redacted | View source |
For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline population for the primary analysis consists of all enrolled patients who survived the index MI hospitalization and did not withdraw before being discharged on clopidogrel or ticagrelor.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care Arm | For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Primary Population | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Gender | Primary Population | Count of Participants | Participants |
| ||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity (Hispanic or Latino) | Primary Population | Count of Participants | Participants |
| ||||||||||||||
| Race/Ethnicity, Customized | Race (White vs. Non-White) | Count of Participants | Participants |
| |||||||||||||||
| Insurance Payors - Private Health Insurance | Patients who have private health insurance | Primary Population | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events | To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge. | Primary Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor | To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge. | Primary Population | Posted | Number | Percentage of Patients | 12 months |
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| Secondary | P2Y12 Receptor Inhibitor Selection | To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge. | Primary Population | Posted | Number | Percentage of Patients | 12 months |
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Safety data was not actively collected in the ARTEMIS trial for the following reasons: • The safety profile of Brilinta (ticagrelor) is well established • ARTEMIS is a non-indication seeking interventional study that did not include a safety objective; the intervention involved co-payment only. Only Deaths were collected over the course of the 15-month study period.
Adverse Events were only assessed with respect to All-Cause Mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 16 | 6,135 | 0 | 0 | 0 | 0 |
| EG001 | Usual Care Arm | For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed. | 8 | 3,967 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Registry Site shall submit to the Committee for its review a copy of any proposed publication resulting from the Registry at least thirty (30) days prior to the date of submission for publication or at least fifteen (15) days prior to submission for an abstract, and if no response is received within sixty (60) days of the date submitted to Sponsor, it will be conclusively presumed that the publication may proceed without delay.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naeem Khan, MD, VP, CVMD TA | AstraZeneca Pharmaceuticals LP | 302-886-5526 | Naeem.Khan@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2017 | Oct 18, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Non-White |
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| Counts |
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| Participants |
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