A Phase 4 interventional study of Study voucher card in Cost Sharing, Acute Coronary Syndrome, sponsored by AstraZeneca. Completed at 272 sites in 2 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by AstraZeneca · Phase 4, Interventional, and Health services research
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 11,001 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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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:
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.
Other: Study voucher card
For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
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.
Time frame: 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.
Time frame: 12 months
P2Y12 Receptor Inhibitor Selection
To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.
Time frame: 12 months
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.
| Milestone | Copayment Intervention Arm | Usual Care Arm |
|---|---|---|
| Started | 6436 | 4565 |
| Completed | 6135 | 3967 |
| Not completed | 301 | 598 |
| Withdrew: Death | 16 | 8 |
| Withdrew: Discharged without p2y12 | 1 | 3 |
| Withdrew: Discharged on prasugrel | 283 | 587 |
| Withdrew: Withdrawal by subject | 1 | 0 |
To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.
| Percentage of Participants | Copayment Intervention Arm | Usual Care Arm |
|---|---|---|
| Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events | 10.17 (9.4 to 10.93) | 10.93 (9.67 to 11.60) |
To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.
| Percentage of Patients | Copayment Intervention Arm | Usual Care Arm |
|---|---|---|
| Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor | 12.96 | 16.21 |
To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.
| Percentage of Patients | Copayment Intervention Arm - Clopidogrel | Copayment Intervention Arm - Ticagrelor | Usual Care Arm - Clopidogrel | Usual Care Arm - Ticagrelor |
|---|---|---|---|---|
| P2Y12 Receptor Inhibitor Selection | 36.0 | 59.6 | 54.7 | 32.4 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Copayment Intervention Arm | 16/6,135 (0.3%) | — | — |
| Usual Care Arm | 8/3,967 (0.2%) | — | — |
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.
| Age, Continuous(Years) | Copayment Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Age | 62.08 ± 11.78 | 62.10 ± 11.55 | 62.09 ± 11.69 |
| Sex: Female, Male(Participants) | Copayment Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Female | 1942 | 1285 | 3227 |
| Male | 4193 | 2682 | 6875 |
| Ethnicity (NIH/OMB)(Participants) | Copayment Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 188 | 222 | 410 |
| Not Hispanic or Latino | 5947 | 3745 | 9692 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Copayment Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Race — White | 5495 | 3416 | 8911 |
| Race — Non-White | 640 | 551 | 1191 |
| Insurance Payors - Private Health Insurance(Participants) | Copayment Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Count of participants | 3864 | 2540 | 6404 |
Showing the first 100 of 272 sites across 2 countries.
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