CLEAR (spironolactone)
Trial question
What is the role of spironolactone in patients with MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 7062
7062 patients (1438 female, 5624 male).
Inclusion criteria: patients with MI who had undergone PCI.
Key exclusion criteria: age < 18 years; pregnancy or lactation; SBP < 90 mmHg; active diarrhea; known allergy or contraindication to everolimus; unable to receive dual antiplatelet therapy; contraindication to spironolactone; cirrhosis or current severe hepatic disease.
Interventions
N=3537 spironolactone (at a dose of 25 mg once daily).
N=3525 placebo (matching placebo).
Primary outcome
Incidence of CV death or new or worsening heart failure
1.7
2.1
2.1/100 py
1.6/100 py
1.1/100 py
0.5/100 py
0.0/100 py
Spironolactone
Placebo
No significant
difference ↔
No significant difference in the incidence of CV death or new or worsening HF (1.7/100 py vs. 2.1/100 py; HR 0.91, 95% CI 0.69 to 1.21).
Secondary outcomes
No significant difference in first occurrence of MI, stroke, new or worsening HF, or CV death (7.9% vs. 8.3%; HR 0.96, 96% CI 0.81 to 1.13).
No significant difference in CV death (3.2% vs. 3.3%; HR 0.98, 95% CI 0.76 to 1.27).
No significant difference in new or worsening HF (1.6% vs. 2.4%; HR 0.77, 95% CI 0.51 to 1.16).
Safety outcomes
No significant differences in death from renal causes, dialysis, renal transplantation, or a sustained drop of at least 40% in the eGFR.
Significant difference in gynecomastia (2.3% vs. 0.5%).
Conclusion
In patients with MI who had undergone PCI, spironolactone was not superior to placebo with respect to the incidence of CV death or new or worsening HF.
Reference
Sanjit S Jolly, Marc-André d'Entremont, Bertram Pitt et al. Routine Spironolactone in Acute Myocardial Infarction. N Engl J Med. 2024 Nov 17. Online ahead of print.
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