NCT04505098
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Ran, enrolled patients, then stopped for a reason unrelated to the science — flagged as possibly worth a second look.
- Phase
- PHASE4
- Enrollment
- 39,600
- Sponsor class
- OTHER
- Taxonomy code
- regulatory_conduct
What the registry says
“The study was suspended by the IRB of record and subsequently terminated”
What real verification found
This is the MITIGATE trial (Pragmatic RandomIzed Trial of Icosapent Ethyl for High-CardiovasculAr Risk Adults) — an Amarin-supported, investigator-initiated, virtual/EHR-based pragmatic trial run inside Kaiser Permanente Northern California, testing whether pre-treatment with icosapent ethyl (Vascepa) reduces viral upper-respiratory-infection (URI)-related morbidity/mortality (COVID-19, flu, other viral pathogens) in adults with established ASCVD. Rationale/design paper: Ambrosy et al., Am Heart J 2021 (PubMed 33516752; ScienceDirect S0002870321000314). Why it stopped (confirmed, not just guessed): this was NOT a quiet business-decision stop. Multiple independent 2025 news sources (AP wire story syndicated via thederrick.com, NewsBreak, and a ground.news aggregation of the same reporting, all citing an internal Kaiser IRB audit obtained by Bay Area News Group) describe a real patient-protection/research-misconduct scandal: Kaiser's IRB found the MITIGATE research team enrolled ineligible participants (including a patient with a known shellfish allergy who was pressured to stay enrolled and had a subsequent adverse reaction), continued recruiting people who had declined, told participants having trouble swallowing capsules to open and take the contents (an unauthorized protocol deviation), and had documentation/data-management failures — plus an attempt by the two lead researchers to withhold/cover up the lapses from oversight bodies. The two researchers (one independently confirmed as Andrew Ambrosy, matching the trial's listed lead investigator on the Kaiser Division of Research site) were disciplined and suspended from ~11 other studies; the trial was halted around December 2022, matching the record's listed completion_date of 2022-12-15 and why_stopped text ("suspended by the IRB of record and subsequently terminated"). This confirms the record's category-A classification: the stop was about conduct/oversight, not a scientific answer — no results were ever published for MITIGATE itself, and I found no evidence of any interim/partial data release. Was the underlying question picked back up? Not by a direct replication of MITIGATE's specific design (pragmatic EHR-based prevention in ASCVD outpatients), but the same drug has since been tested again in a closely related respiratory-infection context: TIN-CAP (NCT06710080, "Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia"), sponsored by the University of Ottawa Heart Institute, registered ~Nov 2024 and actively recruiting as of my search — a multi-center, double-blind, placebo-controlled Phase 3 trial giving icosapent ethyl vs. placebo to adults hospitalized with community-acquired pneumonia, measuring arterial/vascular inflammation via PET-CT over 6 months. This is a genuine but imperfect successor: same intervention (icosapent ethyl) and the same broad hypothesis space (that IPE's anti-inflammatory/pleiotropic effects matter in respiratory infection), but a different population (already-diagnosed CAP inpatients vs. MITIGATE's pre-infection ASCVD outpatient prevention cohort), different primary endpoint (imaging-based vascular inflammation vs. URI-related clinical morbidity/mortality), and a different, more rigorous trial design and sponsor entirely unconnected to Kaiser/MITIGATE. I found no other trial, publication, or regulatory action (FDA label change, competitor drug result, etc.) that would make MITIGATE's original specific question moot.
Full search & fetch trail
WebSearch: "NCT04505098 icosapent ethyl pragmatic trial Kaiser Permanente"; "icosapent ethyl pragmatic randomized trial high cardiovascular risk IRB suspended terminated"; "MITIGATE trial icosapent ethyl terminated results published"; "MITIGATE icosapent ethyl IRB suspended Kaiser 2022"; "MITIGATE trial Kaiser icosapent ethyl waiver of consent controversy stopped"; "Kaiser Permanente Northern California clinical trials division misconduct doctors disciplined Vascepa fish oil"; "MITIGATE trial Kaiser research misconduct audit IRB"; "AP News Kaiser Permanente internal audit halted research disciplined doctors Vascepa fish oil"; "mercurynews.com Kaiser Permanente fish oil study disciplined researchers Vascepa MITIGATE"; "icosapent ethyl omega-3 viral respiratory infection prevention trial 2023 2024 2025 new study"; "MITIGATE Kaiser icosapent ethyl interim results OR partial results OR abstract presented"; "icosapent ethyl respiratory infection prevention new clinical trial registered 2023 2024 successor"; "Vascepa icosapent ethyl community-acquired pneumonia trial NCT phase 3". WebFetch: Kaiser Permanente Division of Research MITIGATE study page; clinicaltrials.gov/study/NCT04505098 (returned only nav chrome, no body content); stocktitan.net Amarin press release; BU SPH article on trial terminations (checked and ruled out — does not mention MITIGATE despite appearing in search, confirming that source was NOT relevant); thederrick.com AP-syndicated article (429 rate-limited on fetch, corroborated via search-result snippets instead); ground.news aggregation page; newsbreak.com article; withpower.com TIN-CAP trial page.