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

Cost Sharing, Acute Coronary Syndrome Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406677
• Other study ID #: D5130R00030
• Status: Completed
• Phase: Phase 4
• Start date: June 5, 2015
• Est. completion date: October 23, 2017

Study information

• Verified date: September 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the impact of copayment reduction on clinician choice of medication, patient adherence, and clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk. This is in part due to greater adherence to an evidence--based secondary prevention medication. Additionally the reduction in MACE may reflect greater selection of a more potent antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment rather than the cost burden to the patient.

Description:

ARTEMIS is a prospective, cluster-randomized clinical trial that will evaluate whether patient copayment elimination significantly influences antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care after acute myocardial infarction. Approximately 11,000 patients with ST-elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) will be enrolled at the approximately 300 hospitals in this study. Study sites selected for ARTEMIS will be geographically diverse, and will represent a diversity of hospital types and capabilities (e.g., teaching hospital, community hospital, etc). After institutional review board (IRB) approval of the study, each hospital will be randomized into either the intervention arm or the control arm. Hospitals randomized to the intervention arm will have the opportunity to offer enrolled patients either clopidogrel (generic P2Y12 receptor inhibitor option) or ticagrelor (brand P2Y12 receptor inhibitor option) without patient contribution to copayment in the next 12 months after the index MI discharge. Hospitals in the control arm will provide care per usual clinical routine. Notably, for both intervention and control arms, all patient management decisions (including the choice of antiplatelet therapy) are completely at the discretion of the care providers. Duration of antiplatelet therapy will also be at the discretion of care providers. All enrolled patients will be followed up to 15 months after index MI discharge to collect data on longitudinal treatment patterns and outcomes. Primary and secondary endpoints will be assessed at 12 months. An additional three months of follow up will assess for antiplatelet persistence and clinical events after discontinuation of the copayment intervention. Centralized follow-up will be conducted every 3 months via telephone or web-based contact.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11001
• Est. completion date: October 23, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cost Sharing, Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	Research Site	Caguas
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Albany	New York
United States	Research Site	Alexandria	Louisiana
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Alpena	Michigan
United States	Research Site	Anchorage	Alaska
United States	Research Site	Anderson	South Carolina
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Annapolis	Maryland
United States	Research Site	Asheville	North Carolina
United States	Research Site	Athens	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Illinois
United States	Research Site	Aurora	Colorado
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bay City	Michigan
United States	Research Site	Belleville	Illinois
United States	Research Site	Bend	Oregon
United States	Research Site	Bethesda	Maryland
United States	Research Site	Billings	Montana
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bloomington	Indiana
United States	Research Site	Bossier City	Louisiana
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Bridgeport	Connecticut
United States	Research Site	Bridgeton	Missouri
United States	Research Site	Bridgewater	New Jersey
United States	Research Site	Brighton	Massachusetts
United States	Research Site	Burlington	Vermont
United States	Research Site	Camp Hill	Pennsylvania
United States	Research Site	Canton	Ohio
United States	Research Site	Chambersburg	Pennsylvania
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Clinton	Maryland
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Maryland
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbia	South Carolina
United States	Research Site	Cooperstown	New York
United States	Research Site	Cottonwood	Arizona
United States	Research Site	Cumming	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Danbury	Connecticut
United States	Research Site	Danville	Pennsylvania
United States	Research Site	Davenport	Iowa
United States	Research Site	Dayton	Ohio
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research Site	Doylestown	Pennsylvania
United States	Research Site	Duluth	Minnesota
United States	Research Site	Durham	North Carolina
United States	Research Site	Englewood	Indiana
United States	Research Site	Escondido	California
United States	Research Site	Fayetteville	Arkansas
United States	Research Site	Fenton	Missouri
United States	Research Site	Flagstaff	Arizona
United States	Research Site	Flemington	New Jersey
United States	Research Site	Flint	Michigan
United States	Research Site	Fort Smith	Arkansas
United States	Research Site	Gainesville	Florida
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Grand Blanc	Michigan
United States	Research Site	Grand Forks	North Dakota
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Greenwood	South Carolina
United States	Research Site	Haddon Heights	New Jersey
United States	Research Site	Haddon Heights	New Jersey
United States	Research Site	Hattiesburg	Mississippi
United States	Research Site	High Point	North Carolina
United States	Research Site	Hollywood	Florida
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Hudson	Florida
United States	Research Site	Huntington Beach	California
United States	Research Site	Huntsville	Alabama
United States	Research Site	Hyannis	Massachusetts
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jackson	Michigan
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville Beach	Florida
United States	Research Site	Johnson City	New York
United States	Research Site	Joliet	Illinois
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	Joplin	Missouri
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kettering	Ohio
United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Crosse	Wisconsin
United States	Research Site	Lakeland	Florida
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Largo	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Loma Linda	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Louisville	Kentucky
United States	Research Site	Louisville	Kentucky
United States	Research Site	Lumberton	North Carolina
United States	Research Site	Lynchburg	Virginia
United States	Research Site	Macon	Georgia
United States	Research Site	Macon	Georgia
United States	Research Site	Marietta	Georgia
United States	Research Site	Marquette	Michigan
United States	Research Site	Memphis	Tennessee
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Middleburg Heights	Ohio
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mobile	Alabama
United States	Research Site	Mobile	Alabama
United States	Research Site	Moorestown	New Jersey
United States	Research Site	Morehead City	North Carolina
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Mount Clemens	Michigan
United States	Research Site	Muncie	Indiana
United States	Research Site	Munster	Indiana
United States	Research Site	New Braunfels	Texas
United States	Research Site	New Haven	Connecticut
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Newark	New Jersey
United States	Research Site	Norfolk	Virginia
United States	Research Site	North Kansas City	Missouri
United States	Research Site	Northridge	California
United States	Research Site	Oak Ridge	Tennessee
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Omaha	Nebraska
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Palestine	Texas
United States	Research Site	Panama City	Florida
United States	Research Site	Pasadena	California
United States	Research Site	Paterson	New Jersey
United States	Research Site	Pensacola	Florida
United States	Research Site	Pensacola	Florida
United States	Research Site	Peoria	Illinois
United States	Research Site	Petoskey	Michigan
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pinehurst	North Carolina
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Pomona	New Jersey
United States	Research Site	Pontiac	Michigan
United States	Research Site	Portland	Oregon
United States	Research Site	Poughkeepsie	New York
United States	Research Site	Puyallup	Washington
United States	Research Site	Racine	Wisconsin
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Reno	Nevada
United States	Research Site	Reno	Nevada
United States	Research Site	Renton	Washington
United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond	Indiana
United States	Research Site	Ridgewood	New Jersey
United States	Research Site	Riverside	California
United States	Research Site	Roanoke	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Rockford	Illinois
United States	Research Site	Rockford	Illinois
United States	Research Site	Rockport	Maine
United States	Research Site	Rockville	Maryland
United States	Research Site	Round Rock	Texas
United States	Research Site	Safety Harbor	Florida
United States	Research Site	Saginaw	Michigan
United States	Research Site	Saint Charles	Missouri
United States	Research Site	Saint Cloud	Minnesota
United States	Research Site	Saint Joseph	Michigan
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Salinas	California
United States	Research Site	Salisbury	Maryland
United States	Research Site	San Antonio	Texas
United States	Research Site	Sarasota	Florida
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Schenectady	New York
United States	Research Site	Scranton	Pennsylvania
United States	Research Site	Sellersville	Pennsylvania
United States	Research Site	Shreveport	Louisiana
United States	Research Site	South Bend	Indiana
United States	Research Site	Southfield	Michigan
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Illinois
United States	Research Site	Stamford	Connecticut
United States	Research Site	Staten Island	New York
United States	Research Site	Stockton	California
United States	Research Site	Stony Brook	New York
United States	Research Site	Suwanee	Georgia
United States	Research Site	Tallahassee	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Teaneck	New Jersey
United States	Research Site	Temple	Texas
United States	Research Site	Thousand Oaks	California
United States	Research Site	Toledo	Ohio
United States	Research Site	Torrance	California
United States	Research Site	Tualatin	Oregon
United States	Research Site	Urbana	Illinois
United States	Research Site	Utica	New York
United States	Research Site	Valhalla	New York
United States	Research Site	Valparaiso	Indiana
United States	Research Site	Vista	California
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Waco	Texas
United States	Research Site	Warren	Michigan
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Waukesha	Wisconsin
United States	Research Site	Webster	Texas
United States	Research Site	West Columbia	South Carolina
United States	Research Site	West Des Moines	Iowa
United States	Research Site	West Reading	Pennsylvania
United States	Research Site	Wilkes-Barre	Pennsylvania
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winchester	Virginia
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Haven	Florida
United States	Research Site	Worcester	Massachusetts
United States	Research Site	York	Pennsylvania
United States	Research Site	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months
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.	12 months
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.	12 months

External Links

•   D5130R00030_CSP_redacted
•   D5130R00030_SAP_Redacted