Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03048825 | Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry | PHASE3 | COMPLETED | 7,264 | — | — | Feb 1, 2018 | Aug 9, 2024 | Oct 15, 2024 | 109 | United States, Australia +12 |
Major Adverse Cardiac Events (MACE) for SYNERGY Stent (defined as the composite of death, recurrent target vessel MI, stroke, or ischemia driven target vessel revascularization) compared to performance goal
The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison
Total composite of cardiovascular death or new or worsening heart failure in the spironolactone comparison (co-primary 1)
The first occurence of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke in the spironolactone comparison (co-primary 2)
| Arm | Type | Description |
|---|---|---|
| Colchicine + Spironolactone +/- SYNERGY Stent | ACTIVE_COMPARATOR | Colchicine 0.5 mg tablet + Spironolactone 25 mg tablet. Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry. |
| Spironolactone +/- SYNERGY Stent | ACTIVE_COMPARATOR | Colchicine-placebo tablet + Spironolactone 25 mg tablet. Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry. |
| Colchicine +/- SYNERGY Stent | ACTIVE_COMPARATOR | Colchicine 0.5 mg tablet + Spironolactone-placebo tablet. Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry. |
| Placebo +/- SYNERGY Stent | PLACEBO_COMPARATOR | Colchicine-placebo tablet + Spironolactone-placebo tablet. Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry. |
| Name | Type | Description |
|---|---|---|
| Colchicine | DRUG | Colchicine 0.5 mg once daily |
| Spironolactone | DRUG | Spironolactone 25 mg once daily |
| SYNERGY Bioabsorbable Polymer Drug-Eluting Stent | DEVICE | Trial participants who receive a SYNERGY™ Bioabsorbable Polymer Drug-Eluting (everolimus) Stent during their index PCI for STEMI will be included in the SYNERGY Stent Registry. |
| Colchicine-Placebo | DRUG | Matching Colchicine-placebo once daily |
| Spironolactone-Placebo | DRUG | Matching Spironolactone-Placebo once daily |
Inclusion Criteria: 1. a) Patients with STEMI referred for PCI within 12 hours of symptom onset, have a culprit lesion amenable to stenting, and with planned SYNERGY stent implantation for SYNERGY registry OR b) Patients with STEMI referred for PCI within 48 hours of symptom onset, not pros...