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A Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies

Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial: a Randomized Evaluation of First-dollar Coverage for Post-MI Secondary Preventive Therapies

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00566774
Acronym
MI FREEE
Enrollment
5860
Registered
2007-12-04
Start date
2007-11-30
Completion date
2010-11-30
Last updated
2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction

Keywords

myocardial infarction, secondary prevention, health insurance, cost-sharing

Brief summary

The objective of this randomized trial is to evaluate the effect of providing full prescription drug coverage (i.e. no co-pays, co-insurance or deductibles) for statins, beta-blockers, angiotensin converting enzyme inhibitors and angiotensin II receptor blockers to patients recently discharged from hospital after acute myocardial infarction.

Interventions

OTHERFull drug coverage

Patients randomized to first-dollar coverage will have their pharmacy benefits changed so that they have no out-of-pocket costs for any beta-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) antagonist, or statin for every subsequent prescription after randomization. All co-pays and co-insurance will be waived at the point of care (i.e. pharmacy) as will any contribution that the cost of these drugs contributes to a patient's deductible

OTHERUsual coverage

Patients randomized to usual coverage will have no change in their existing benefits

Sponsors

Aetna, Inc.
CollaboratorINDUSTRY
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* discharged alive from hospital after acute MI * receive health services and prescription drug benefits through Aetna, Inc.

Exclusion criteria

* enrollment in a Health Savings Account (HSA) plan * age ≥ 65 years of age at the time of hospital discharge * plan sponsor has opted out of participating in the study * receive only medical services or pharmacy coverage but not both through Aetna

Design outcomes

Primary

MeasureTime frame
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)2.5 years

Secondary

MeasureTime frame
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure or out-of-hospital cardiac death2.5 years
Rate of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)2.5 years
First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure2.5 years
Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)3 months
Total pharmacy and health care costs2.5 years
Medication adherence (i.e. the mean medication possession ratio and the proportion of patients fully adherent to each and all 3 of the study medications)3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026