Skip to main content
OpenTrials
Completed

NCT Number: NCT00566774

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aetna Inc

Hartford, Connecticut, 06156, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full drug coverage

Other

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

Usual coverage

Other

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

Primary outcomes

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

    Time frame: 2.5 years

Secondary outcomes

  1. First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure

    Time frame: 2.5 years

  2. First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, or congestive heart failure or out-of-hospital cardiac death

    Time frame: 2.5 years

  3. Rate of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty)

    Time frame: 2.5 years

  4. 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)

    Time frame: 3 months

  5. Health care utilization (i.e. use of physician visits, emergency room admissions, hospitalizations or other resources)

    Time frame: 3 months

  6. Total pharmacy and health care costs

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Aetna, Inc.

Registry information

Official study title

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

Acronym: MI FREEE

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 4, 2007
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.