Evidence map›Paper›PMID 33516752›Full record

ArticleAmerican heart journal2021

Rationale and design of the pragmatic randomized trial of icosapent ethyl for high cardiovascular risk adults (MITIGATE).

Andrew P Ambrosy, Umar I Malik, Rachel C Thomas, Rishi V Parikh, Thida C Tan, Choon H Goh, Van N Selby, Matthew D Solomon, Harshith R Avula, Jesse K Fitzpatrick and 5 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in American heart journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Review
  3. A Critical Review of Icosapent Ethyl in Cardiovascular Risk Reduction.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023
    Review
  4. Review
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Andrew P AmbrosyDepartment of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA; Division of Research, Kaiser Permanente Northern California, Oakland, CA. Electronic address: andrew.p.ambrosy@kp.org.
Umar I MalikDepartment of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.
Rachel C ThomasDivision of Research, Kaiser Permanente Northern California, Oakland, CA.
Rishi V ParikhDivision of Research, Kaiser Permanente Northern California, Oakland, CA.
Thida C TanDivision of Research, Kaiser Permanente Northern California, Oakland, CA.
Choon H GohDepartment of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.
Van N SelbyDepartment of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.
Matthew D SolomonDivision of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Cardiology, Kaiser Permanente Oakland Medical Center, Oakland, CA.
Harshith R AvulaDepartment of Cardiology, Kaiser Permanente Walnut Creek Medical Center, Walnut Creek, CA.
Jesse K FitzpatrickDepartment of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.
Jacek SkarbinskiDivision of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Infectious Disease, Kaiser Permanente Oakland Medical Center, Oakland, CA.
Sephy PhilipAmarin Pharma, Inc., Bridgewater, NJ.
Craig GranowitzAmarin Pharma, Inc., Bridgewater, NJ.
Deepak L BhattBrigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA.
Alan S GoDivision of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA; Departments of Medicine (Nephrology), Epidemiology, and Biostatistics, University of California, San Francisco, San Francisco, CA; Department of Medicine (Nephrology), Stanford University, Palo Alto, CA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD).

backgroundIPE is a highly purified and stable omega-3 fatty acid prescription medication that is approved for cardiovascular risk reduction in high-risk adults on statin therapy with elevated triglycerides. Preclinical data and clinical observations suggest that IPE may have pleiotropic effects including antiviral and anti-inflammatory properties that may prevent or reduce the downstream sequelae and cardiopulmonary consequences of viral URIs.

methodsMITIGATE is a virtual, electronic health record-based, open-label, randomized, pragmatic clinical trial enrolling ∼16,500 participants within Kaiser Permanente Northern California - a fully integrated and learning health care delivery system with 21 hospitals and >255 ambulatory clinics serving ∼4.5 million members. Adults ≥50 years with established ASCVD and no prior history of coronavirus disease 2019 (COVID-19) will be prospectively identified and pre-randomized in a 1:10 allocation ratio (∼ 1,500 IPE: ∼15,000 usual care) stratified by age and previous respiratory health status to the intervention (IPE 2 grams by mouth twice daily with meals) vs the control group (usual care) for a minimum follow-up duration of 6 months. The co-primary endpoints are moderate-to-severe laboratory-confirmed viral URI and worst clinical status due to a viral URI at any point in time.

conclusionThe MITIGATE study will inform clinical practice by providing evidence on the real-world clinical effectiveness of pretreatment with IPE to prevent and/or reduce the sequelae of laboratory-confirmed viral URIs in a high-risk cohort of patients with established ASCVD.

Indexed as

AtherosclerosisCardiovascular DiseasesCOVID-19Eicosapentaenoic AcidPlatelet Aggregation InhibitorsAgedFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIntention to Treat AnalysisMaleMiddle AgedMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicEicosapentaenoic Acideicosapentaenoic acid ethyl esterHydroxymethylglutaryl-CoA Reductase InhibitorsPlatelet Aggregation InhibitorsAtherosclerotic cardiovascular diseasecoronavirus disease 2019icosapent ethylseasonal flutriglyceridesviral upper respiratory infection

Identifiers

PMID33516752
PMCPMC7843090

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.