Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02406677
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2015-03-30
Brief Title:
Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEMIS
Brief 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
Detailed 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 11000 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None