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Diao, Kaiyue, Wang, Duolao 
ORCID: https://orcid.org/0000-0003-2788-2464, Chen, Zhongxiu, Wu, Xi, Ma, Min, Zhu, Ye, Zhang, Li, Wang, Hua, Wang, Mian, He, Sen, Li, Chen, Deng, Qiao, Yan, Ting, Wu, Tao, Tang, Lu, Huang, Baotao, Sun, Jiayu and He, Yong
(2021)
'Rationale and design of a multi‐center, prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST ‐elevation myocardial infarction: The PERI‐STEMI study'. Clinical Cardiology, Vol 44, Issue 12, pp. 1709-1717.
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Abstract
Background
Angiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan has been recommended as one of the first-line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST-segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.
Hypothesis
We hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6-month follow-up.
Methods
PERI-STEMI is an investigator-initiated, prospective, multi-center, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 376 first-time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril-valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post-PPCI. The primary endpoint is the change of indexed LV mass at the 6-month follow-up CMR.
Results
Enrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.
Conclusions
The results of the PERI-STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR-based risk stratification and therapy selection for these patients. PERI-STEMI is registered at ClinicalTrials.gov (NCT04912167).
| Item Type: | Article |
|---|---|
| Subjects: | QV Pharmacology > QV 38 Drug action. WG Cardiovascular System > WG 100 General works WG Cardiovascular System > WG 20 Research (General) |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1002/clc.23744 |
| Depositing User: | Stacy Murtagh |
| Date Deposited: | 05 Nov 2021 14:47 |
| Last Modified: | 25 Jan 2022 13:07 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/19345 |
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