Speakers
Mikhail Kosiborod, MD
Vice President of Research
Saint Luke’s Health System
Professor of Medicine
University of Missouri-Kansas City
Keywords
Pragmatic Clinical Trials
Key Points
- EVOLVE-MI is testing an important clinical hypothesis that aggressive LDL lowering for patients with atherosclerotic cardiovascular disease immediately after an acute coronary syndrome can actually improve patient outcomes. There is little question about the utility of LDL lowering as a means of cardiovascular risk reduction. This study is looking at a particular subpopulation, where there is a lack of outcomes data.
- EVOLVE-MI is a pragmatic, effectiveness outcome trial of Evolocumab dosed within 10 days of a myocardial infarction (MI). Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. The primary endpoint is a composite of total events including first and recurrent MI, ischemic stroke, any arterial revascularization, and death from any cause.
- This is a collaborative study with Academic-Industry Partnership with oversight by an Academic Executive Committee. EVOLVE-MI has trial innovation through its Academic Research Organizations (AROs), who are also enrolling and understand challenges firsthand.
- Patient recruitment is through a network of sites in different geographic locations managed by a collaboration of AROs. EVOLVE-MI is enrolling 4,000 patients in 3 countries. Study participants are managed within health systems in-line with local standard of care. EVOLVE-MI has trial design and infrastructure innovations, including automated data collection and leveraging Swedish registries.
- EVOLVE-MI has several innovations in protocol development, including streamlined inclusion/exclusion criteria, minimal procedures and ability to screen/randomize in the same day, a simplified schedule of events, and streamlined safety.
- So far EVOLVE-MI’s early experience in the trial has been that nearly every site enrolled a patient within days of activation. The recruitment rate is higher than what you would expect in a normal ACS trial.
Discussion Themes
– Is the trial being done under an IND or is it under label? The treatment is on-label because anyone with an acute coronary has at risk cardiovascular disease so technically it is on-label. Can it be done under an IND. In general, what we’ve done in the past for PCTs like this is that they could be done under an IND.
– The randomization unit is at the patient level, and they do sign an informed consent. Patients are approached by the study team at the hospital and receive their initial treatment in the hospital or standard of care with data collection.
– Could you talk a little bit more about hybrid data collection? In a traditional trial you would have study staff identify outcome events and they would enter them in a data capture form. In our study the staff could add the events, but for example in Sweden, where the data has been shown to be better detailed in the national registry, the folks in the Swedish trials is randomized and the follow up data is collected in the national registry.
Tags
#pctGR, @Collaboratory1