Rationale and design of the RESTORE trial: A multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the effect of Shenfu injection on myocardial injury in STEMI patients after primary PCI
Study context
- Population
- Patients with first-time anterior STEMI undergoing primary PCI within 12 h of symptom onset, 10 centres in mainland Chinaplanned enrolment
- Participants
- 326 patients
- Planned comparison
- Shenfu injection vs placebo
- Primary endpoint
- Infarct size by cardiac magnetic resonance (CMR)
- Follow-up
- 5±2 days after PPCI
Methodological detailsdesign and rationale, multicentre, double-blind, parallel-group, placebo-controlled, 1:1 randomisation
- Design and rationale
- Multicentre
- Double-blind
- Parallel-group
- Placebo-controlled
- 1:1 randomisation
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of the RESTORE trial: A multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the effect of Shenfu injection on myocardial injury in STEMI patients after primary PCI. Am Heart J. Published 22 February 2023. doi:10. 1016/ j. ahj. 2023. 02. 005
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