Study protocol and baseline characteristics of Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and Eicosapentaenoic Acid: RESPECT-EPA, the combination of a randomized control trial and an observational biomarker study
Study context
- Population
- Secondary prevention patients with a low eicosapentaenoic acid (EPA)/AA ratio on statin therapy, JapanRandomized controlled trial (RCT)
- Participants
- 2,460 patients
- Comparison
- Highly purified EPA vs control
- Primary endpoint
- CV death, non-fatal MI, non-fatal ischemic stroke, unstable angina pectoris and clinically indicated coronary revascularization
Methodological detailsopen-label, prospective cohort biomarker study, multicentre (95 sites in Japan)
- Open-label
- Prospective cohort biomarker study
- Multicentre (95 sites in Japan)
Primary result
As reported in the abstract
Baseline median EPA/AA ratio · baseline
EPA
0.243
median
Control
0.235
median
Further findings
Baseline median EPA/AA ratio, observational biomarker study
- Median EPA/AA ratio (n = 1,314)
- 0.577
Original publication
Study protocol and baseline characteristics of Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and Eicosapentaenoic Acid: RESPECT-EPA, the combination of a randomized control trial and an observational biomarker study. Am Heart J. Published 11 November 2022. doi:10.
Summarised from the published abstract; every number is checked against it