drugset / Trial / NCT02861534
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
Phase 3
Completed
5050 enrolled
Merck Sharp & Dohme LLC
Bayer · collabCanadian VIGOUR Centre · collabDuke Clinical Research Institute · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.
Timeline
- Start
- 2016-09-20
- Primary completion
- 2019-06-18
- Completion
- 2019-09-02
Outcome
Met primary endpoint
registry analysis (superiority test); Vericiguat vs Placebo; p = 0.019; Hazard Ratio (HR) 0.90 (95% CI 0.82 to 0.98); Cox proportional hazard model NCT02861534 ↗
paper a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group PMID 32222134 ↗
release “In the VICTORIA trial, vericiguat met its primary endpoint” merck.com ↗
Publications
- Results Pieske B, Patel MJ, Westerhout CM, Anstrom KJ, Butler J, Ezekowitz J, Hernandez AF, Koglin J, Lam CSP, Ponikowski P, Roessig L, Voors AA, O'Connor CM, Armstrong PW; VICTORIA Study Group. Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial. Eur J Heart Fail. 2019 Dec;21(12):1596-1604. doi: 10.1002/ejhf.1664. Epub 2019 Dec 9.
- Shah P, Zheng Y, Pieske B, Melenovsky V, Lam CSP, Sliwa K, Butler J, Ezekowitz JA, deFilippi CR, O'Connor CM, Sandhu RK, Roessig L, Tromp J, Westerhout CM, Voors AA, Armstrong PW; VICTORIA Study Group. Phenomapping in Heart Failure With Reduced Ejection Fraction to Identify Subpopulations With High Residual Risk: A VICTORIA Substudy. Circ Heart Fail. 2026 Feb;19(2):e013166. doi: 10.1161/CIRCHEARTFAILURE.125.013166. Epub 2025 Oct 8.
- Khan MS, Butler J, Young R, Lewis BS, Escobedo J, Refsgaard J, Reyes E, Roessig L, Blaustein RO, Lam CSP, Voors AA, Ponikowski P, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Vericiguat and Cardiovascular Outcomes in Heart Failure by Baseline Diabetes Status: Insights From the VICTORIA Trial. JACC Heart Fail. 2024 Oct;12(10):1750-1759. doi: 10.1016/j.jchf.2024.05.007. Epub 2024 Jun 26.
- Mentz RJ, Stebbins A, Butler J, Chiang CE, Ezekowitz JA, Hernandez AF, Hilkert R, Lam CSP, McDonald K, O'Connor CM, Pieske B, Ponikowski P, Roessig L, Sweitzer NK, Voors AA, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Recurrent Hospitalizations and Response to Vericiguat in Heart Failure and Reduced Ejection Fraction. JACC Heart Fail. 2024 May;12(5):839-846. doi: 10.1016/j.jchf.2023.12.005. Epub 2024 Feb 14.
- Chew DS, Li Y, Bigelow R, Cowper PA, Anstrom KJ, Daniels MR, Davidson-Ray L, Hernandez AF, O'Connor CM, Armstrong PW, Mark DB; VICTORIA Study Group. Cost-Effectiveness of Vericiguat in Patients With Heart Failure With Reduced Ejection Fraction: The VICTORIA Randomized Clinical Trial. Circulation. 2023 Oct 3;148(14):1087-1098. doi: 10.1161/CIRCULATIONAHA.122.063602. Epub 2023 Sep 6.
- Lam CSP, Pina IL, Zheng Y, Bonderman D, Pouleur AC, Saldarriaga C, Pieske B, Blaustein RO, Nkulikiyinka R, Westerhout CM, Armstrong PW; VICTORIA Study Group. Age, Sex, and Outcomes in Heart Failure With Reduced EF: Insights From the VICTORIA Trial. JACC Heart Fail. 2023 Sep;11(9):1246-1257. doi: 10.1016/j.jchf.2023.06.020. Epub 2023 Aug 9.
- Armstrong PW, Zheng Y, Lund LH, Butler J, Troughton RW, Emdin M, Lam CSP, Ponikowski P, Blaustein RO, O'Connor CM, Roessig L, Voors AA, Ezekowitz JA, Westerhout CM; VICTORIA Study Group. Evolution of NT-proBNP During Prerandomization Screening in VICTORIA: Implications for Clinical Outcomes and Efficacy of Vericiguat. Circ Heart Fail. 2023 Oct;16(10):e010661. doi: 10.1161/CIRCHEARTFAILURE.123.010661. Epub 2023 Jul 28.
- Ezekowitz JA, McMullan CJ, Westerhout CM, Pina IL, Lopez-Sendon J, Anstrom KJ, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Ponikowski P, Roessig L, Voors AA, Koglin J, Armstrong PW, Butler J; VICTORIA Study Group. Background Medical Therapy and Clinical Outcomes From the VICTORIA Trial. Circ Heart Fail. 2023 Sep;16(9):e010599. doi: 10.1161/CIRCHEARTFAILURE.123.010599. Epub 2023 Jul 7.
- Felker GM, North R, Mulder H, Jones WS, Anstrom KJ, Patel MJ, Butler J, Ezekowitz JA, Lam CSP, O'Connor CM, Roessig L, Hernandez AF, Armstrong PW; VICTORIA Study Group. Classification of Heart Failure Events by Severity: Insights From the VICTORIA Trial. J Card Fail. 2023 Aug;29(8):1113-1120. doi: 10.1016/j.cardfail.2023.04.015. Epub 2023 Jun 17.
- Butler J, Zheng Y, Khan MS, Bonderman D, Lund LH, deFilippi CR, Blaustein RO, Ezekowitz JA, Freitas C, Hernandez AF, O'Connor CM, Voors AA, Westerhout CM, Lam CSP, Armstrong PW; VICTORIA Study Group. Ejection Fraction, Biomarkers, and Outcomes and Impact of Vericiguat on Outcomes Across EF in VICTORIA. JACC Heart Fail. 2023 May;11(5):583-592. doi: 10.1016/j.jchf.2022.12.014. Epub 2023 Apr 12.
- Armstrong PW, Zheng Y, Troughton RW, Lund LH, Zhang J, Lam CSP, Westerhout CM, Blaustein RO, Butler J, Hernandez AF, Roessig L, O'Connor CM, Voors AA, Ezekowitz JA; VICTORIA Study Group. Sequential Evaluation of NT-proBNP in Heart Failure: Insights Into Clinical Outcomes and Efficacy of Vericiguat. JACC Heart Fail. 2022 Sep;10(9):677-688. doi: 10.1016/j.jchf.2022.04.015. Epub 2022 Jul 6.
- Senni M, Lopez-Sendon J, Cohen-Solal A, Ponikowski P, Nkulikiyinka R, Freitas C, Vlajnic VM, Roessig L, Pieske B. Vericiguat and NT-proBNP in patients with heart failure with reduced ejection fraction: analyses from the VICTORIA trial. ESC Heart Fail. 2022 Dec;9(6):3791-3803. doi: 10.1002/ehf2.14050. Epub 2022 Jul 26.
- Senni M, Alemayehu WG, Sim D, Edelmann F, Butler J, Ezekowitz J, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Ponikowski P, Roessig L, Voors AA, Westerhout CM, McMullan C, Armstrong PW; VICTORIA Study Group. Efficacy and safety of vericiguat in patients with heart failure with reduced ejection fraction treated with sacubitril/valsartan: insights from the VICTORIA trial. Eur J Heart Fail. 2022 Sep;24(9):1614-1622. doi: 10.1002/ejhf.2608. Epub 2022 Jul 20.
- Butler J, Stebbins A, Melenovsky V, Sweitzer NK, Cowie MR, Stehlik J, Khan MS, Blaustein RO, Ezekowitz JA, Hernandez AF, Lam CSP, Nkulikiyinka R, O'Connor CM, Pieske BM, Ponikowski P, Spertus JA, Voors AA, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial. Circ Heart Fail. 2022 Jun;15(6):e009337. doi: 10.1161/CIRCHEARTFAILURE.121.009337. Epub 2022 Jun 3.
- Lam CSP, Mulder H, Lopatin Y, Vazquez-Tanus JB, Siu D, Ezekowitz J, Pieske B, O'Connor CM, Roessig L, Patel MJ, Anstrom KJ, Hernandez AF, Armstrong PW; VICTORIA Study Group. Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial. J Am Heart Assoc. 2021 Nov 16;10(22):e021094. doi: 10.1161/JAHA.121.021094. Epub 2021 Nov 6.
- Ezekowitz JA, Zheng Y, Cohen-Solal A, Melenovsky V, Escobedo J, Butler J, Hernandez AF, Lam CSP, O'Connor CM, Pieske B, Ponikowski P, Voors AA, deFilippi C, Westerhout CM, McMullan C, Roessig L, Armstrong PW. Hemoglobin and Clinical Outcomes in the Vericiguat Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA). Circulation. 2021 Nov 2;144(18):1489-1499. doi: 10.1161/CIRCULATIONAHA.121.056797. Epub 2021 Aug 25.
- Ezekowitz J, Mentz RJ, Westerhout CM, Sweitzer NK, Givertz MM, Pina IL, O'Connor CM, Greene SJ, McMullan C, Roessig L, Hernandez AF, Armstrong PW. Participation in a Heart Failure Clinical Trial: Perspectives and Opportunities From the VICTORIA Trial and VICTORIA Simultaneous Registry. Circ Heart Fail. 2021 Sep;14(9):e008242. doi: 10.1161/CIRCHEARTFAILURE.120.008242. Epub 2021 Aug 19.
- Mentz RJ, Mulder H, Mosterd A, Sweitzer NK, Senni M, Butler J, Ezekowitz JA, Lam CSP, Pieske B, Ponikowski P, Voors AA, Anstrom KJ, Armstrong PW, O'Connor CM, Hernandez AF; VICTORIA Study Group. Clinical Outcome Predictions for the VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) Trial. J Card Fail. 2021 Jun 24:S1071-9164(21)00206-2. doi: 10.1016/j.cardfail.2021.05.016. Online ahead of print.
- Lam CSP, Giczewska A, Sliwa K, Edelmann F, Refsgaard J, Bocchi E, Ezekowitz JA, Hernandez AF, O'Connor CM, Roessig L, Patel MJ, Pieske B, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial. JAMA Cardiol. 2021 Jun 1;6(6):706-712. doi: 10.1001/jamacardio.2020.6455.
- Ezekowitz JA, O'Connor CM, Troughton RW, Alemayehu WG, Westerhout CM, Voors AA, Butler J, Lam CSP, Ponikowski P, Emdin M, Patel MJ, Pieske B, Roessig L, Hernandez AF, Armstrong PW. N-Terminal Pro-B-Type Natriuretic Peptide and Clinical Outcomes: Vericiguat Heart Failure With Reduced Ejection Fraction Study. JACC Heart Fail. 2020 Nov;8(11):931-939. doi: 10.1016/j.jchf.2020.08.008. Epub 2020 Oct 7.
- Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
- Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA, Lam CSP, Ponikowski P, Temple T, Pieske B, Ezekowitz J, Hernandez AF, Koglin J, O'Connor CM. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104. doi: 10.1016/j.jchf.2017.08.013. Epub 2017 Oct 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vericiguat | Other / unclassified | 10 mg | Oral |