Phase 4
Completed N=11,001
Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
Cost Sharing, Acute Coronary Syndrome
Source: ClinicalTrials.gov NCT02406677 ↗
Enrolled (actual)
11,001
Serious AEs
—
Results posted
Oct 2019
Primary outcomePrimary: Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events — 10.17; 10.93 Percentage of Participants — p=0.3503
◆ Published Evidence
Emerging
17citations · ~3 / year
Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS 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.
Linked Publications (5)
-
Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial.
-
Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.
-
Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial.
-
Challenge in Predicting Persistence to P2Y12 Inhibitors: A Perspective From the ARTEMIS Trial.
-
Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events |
10.17; 10.93 | 0.3503 |
| PRIMARY Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor |
12.96; 16.21 | 0.0260 sig |
| SECONDARY P2Y12 Receptor Inhibitor Selection |
36.0; 59.6; 54.7; 32.4 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02406677) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.