Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS)
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|ClinicalTrials.gov Identifier: NCT02406677|
Recruitment Status : Completed
First Posted : April 2, 2015
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cost Sharing, Acute Coronary Syndrome||Other: Study voucher card||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11001 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study|
|Actual Study Start Date :||June 5, 2015|
|Actual Primary Completion Date :||October 23, 2017|
|Actual Study Completion Date :||October 23, 2017|
Experimental: Copayment Intervention Arm
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
Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
No Intervention: Usual Care Arm
For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
- Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events [ Time Frame: 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.
- Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor [ Time Frame: 12 months ]To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.
- P2Y12 Receptor Inhibitor Selection [ Time Frame: 12 months ]To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406677
|Principal Investigator:||Tracy Wang, MD, MHS, MSc||Duke University|
|Study Chair:||Eric Peterson, MD, MPH, FAHA, FACC||Duke University|