Phase 4 N=11,001 Randomized Health Services Research

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

Cost Sharing, Acute Coronary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02406677 ↗

Enrolled (actual)

11,001

Serious AEs

—

Results posted

Oct 2019

Primary outcome: Primary: Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events — 10.17; 10.93 Percentage of Participants — p=0.3503

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Study voucher card (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Oct 2017

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02406677). 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.