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



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 127
Updated:10/25/2017
Start Date:June 5, 2015
End Date:October 1, 2017

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
248
sites
?
mi
from
Columbia, MD
Click here to add this to my saved trials
?
mi
from
Abington, PA
Click here to add this to my saved trials
?
mi
from
Abington, PA
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Alpena, MI
Click here to add this to my saved trials
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Aurora, IL
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bay City, MI
Click here to add this to my saved trials
?
mi
from
Belleville, IL
Click here to add this to my saved trials
?
mi
from
Bend, OR
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
?
mi
from
Bossier City, LA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
?
mi
from
Brighton, MA
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Caguas,
Click here to add this to my saved trials
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Chambersburg, Pennsylvania 17201
?
mi
from
Chambersburg, PA
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Clinton, MD
Click here to add this to my saved trials
?
mi
from
Coeur D'Alene, ID
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Cooperstown, NY
Click here to add this to my saved trials
?
mi
from
Cottonwood, AZ
Click here to add this to my saved trials
?
mi
from
Cumming, GA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Danville, PA
Click here to add this to my saved trials
?
mi
from
Davenport, IA
Click here to add this to my saved trials
?
mi
from
Davenport, IA
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
?
mi
from
Duluth, MN
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Englewood, IN
Click here to add this to my saved trials
?
mi
from
Escondido, CA
Click here to add this to my saved trials
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
?
mi
from
Fenton, MO
Click here to add this to my saved trials
?
mi
from
Flagstaff, AZ
Click here to add this to my saved trials
?
mi
from
Flemington, NJ
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Fort Smith, AR
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
?
mi
from
Grand Forks, ND
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greenwood, South Carolina 29646
?
mi
from
Greenwood, SC
Click here to add this to my saved trials
Haddon Heights, New Jersey 08035
?
mi
from
Haddon Heights, NJ
Click here to add this to my saved trials
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hudson, FL
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Hyannis, MA
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials