NCT02406677: ARTEMIS

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

Completed Phase 4 Results posted Last updated 1 October 2019

What this trial tests

Phase 4 trial testing Study voucher card in Cost Sharing, Acute Coronary Syndrome in 11,001 participants. Completed in 23 October 2017.

Timeline

5 June 2015

Primary endpoint
23 October 2017

23 October 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	11,001
Start date	5 June 2015
Primary completion	23 October 2017
Estimated completion	23 October 2017
Sites	272 locations across Puerto Rico, United States

Drugs / interventions tested

• Study voucher card

Conditions studied

• Cost Sharing, Acute Coronary Syndrome — all drugs for Cost Sharing, Acute Coronary Syndrome →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Cost Sharing, Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events Primary · 12 months

To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.

Group	Value	95% CI
Copayment Intervention Arm	10.17	9.4 – 10.93
Usual Care Arm	10.93	9.67 – 11.60

Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor Primary · 12 months

To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.

Group	Value	95% CI
Copayment Intervention Arm	12.96
Usual Care Arm	16.21

P2Y12 Receptor Inhibitor Selection Secondary · 12 months

To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.

Group	Value	95% CI
Copayment Intervention Arm - Clopidogrel	36.0
Copayment Intervention Arm - Ticagrelor	59.6
Usual Care Arm - Clopidogrel	54.7
Usual Care Arm - Ticagrelor	32.4

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial.
   Wang TY, Kaltenbach LA, Cannon CP, Fonarow GC, et al · · 2019 · cited 66× · PMID 30620370 · DOI 10.1001/jama.2018.19791
2. Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial.
   Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, et al · · 2020 · cited 12× · PMID 32129795 · DOI 10.1001/jamacardio.2020.0125
3. Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.
   Doll JA, Kaltenbach LA, Anstrom KJ, Cannon CP, et al · · 2020 · cited 8× · PMID 32299284 · DOI 10.1161/jaha.119.014975
4. Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial.
   Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, et al · · 2020 · cited 8× · PMID 31721978 · DOI 10.1001/jamacardio.2019.4408
5. Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial.
   Fanaroff AC, Peterson ED, Kaltenbach LA, Anstrom KJ, et al · · 2020 · cited 6× · PMID 32393129 · DOI 10.1161/circoutcomes.119.006182
6. Challenge in Predicting Persistence to P2Y12 Inhibitors: A Perspective From the ARTEMIS Trial.
   Rymer JA, Wegermann ZK, Kaltenbach LA, Webb LE, et al · · 2023 · cited 2× · PMID 37301758 · DOI 10.1161/jaha.122.029063
7. Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS.
   Rymer JA, Kaltenbach LA, Peterson ED, Cohen DJ, et al · · 2022 · cited 1× · PMID 36250667 · DOI 10.1161/jaha.122.026421