Autopsy report · NCT04505098

A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

“The study was suspended by the IRB of record and subsequently terminated”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 2 years 4 months before it stopped.
• 39,600 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Kaiser Permanente

Sponsor type

University, hospital or other

Conditions

Covid19; Atherosclerosis; Cardiovascular Diseases; Upper Respiratory Tract Infections

Interventions

Icosapent ethyl

Participants

39,600

Sites

1

Countries

United States

Trials that died the same way

• Reducing Frailty for Older Cancer Survivors Using Supplements II
  “The study has been suspended by the IRB pending review of a study-related issue” (82% match in meaning)
• RCT Investigating Pre-cesarean Vaginal Wash of Chlorhexidine vs Povidone-iodine for Patient With Ruptured Amniotic Membrane.
  “The study was withdrawn from the IRB” (81% match in meaning)
• Adherence to Otezla
  “Terminated IRB approval 6/26/2024, study was never initiated or activated” (81% match in meaning)
• A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
  “The IRB which was overseeing the study stopped overseeing it” (78% match in meaning)
• Antibiotics and Tissue Expanders in Breast Reconstruction
  “The study was withdrawn prior to IRB approval.” (78% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.