STEMI
Conditions
Keywords
ST-elevation myocardial infarction (STEMI), cardiovascular magnetic resonance (CMR), angiotensin receptor neprilysin inhibitor (ARNI), angiotensin-converting enzyme inhibitor (ACEI)
Brief summary
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 ST-elevation myocardial infarction (STEMI) than enalapril.
Interventions
DRUGSacubitril-Valsartan
After initiation of the treatment of sacubitril/valsartan, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (24/26 mg, 49/51 mg and 97/103 mg, twice daily)
DRUGEnalapril
After initiation of the treatment of enalapril, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (2.5 mg, 5 mg, and 10 mg,twice daily)
DRUGValsartan
For patients who were previously treated with ACEI and receiving the last dose of that agent during the last 36 hours prior to randomization, Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day was used.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 - 75 years old * First-time ST-segment elevation myocardial infarction based on the newest ESC guidelines * Timely primary percutaneous coronary intervention within 12 hours from onset * Written informed consent acquired
Exclusion criteria
* Known history of or persistent clinical chronic heart failure prior to randomization * Previous use of ARNI, or intolerance or contraindications to study drugs including ARNI or ACEI * History of significant chronic coronary obstruction and adverse ventricular remodeling * History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent or CABG, or planned open-heart surgery within 3 months * History of hepatic impairment or history of cirrhosis with evidence of portal hypertension * History of chronic renal dysfunction, or eGFR \< 30 ml/min/1.73 m2 * History of malignancy and with a life span less than one year * Patients with a known history of angioedema related to previous ACEIs/ARB therapy. * With contraindication to MRI examination (pacemaker and claustrophobia) or cannot finish breath-holding when lying on the examination bed * Pregnancy or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV remodeling index on CMR | 6 months | change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular (LV) ejection fraction | 6 months | left ventricular ejection fraction indexes at the 6-month CMR. |
| global peak LV longitudinal strain | 6 months | global peak LV longitudinal strain at the 6-month CMR. |
| myocardial fibrosis | 6 months | extracelluar volume measured through T1 mapping sequence at the 6-month CMR. |
| Time to the first occurrence of a composite endpoint of adverse clinical events | up to approximately 60 months | including all deaths (cardiac death vs non-cardiac death), non-fatal myocardial re-infarction, hospitalization for worsening heart failure or need for advanced HF therapies (hospital stay \> 24 hours)(e.g., intravenous use of inotropes, left ventricular assist device placement, or cardiac transplantation) |
Countries
China
Outcome results
None listed