Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Colchicine · 1 trial · 2 indications
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...
Colchicine is an investigational small molecule being studied for use in ST Elevation Myocardial Infarction (STEMI). It is being evaluated in a Phase 3 clinical trial to determine its safety and efficacy in patients who have experienced this type of heart attack. The drug is not yet approved and remains in clinical development.
Colchicine is a small molecule that works by targeting inflammatory pathways. While the specific molecular target is not detailed, its mechanism involves reducing inflammation, which is relevant in the setting of myocardial infarction. The drug is being studied for its potential to improve outcomes in patients with ST Elevation Myocardial Infarction.
Colchicine is being developed by Boston Scientific Corporation, a company publicly traded under the ticker symbol BSX. Boston Scientific is conducting a Phase 3 clinical trial to evaluate the drug for the treatment of ST Elevation Myocardial Infarction. The trial is sponsored and managed by the company.
Colchicine is currently in Phase 3 clinical development for ST Elevation Myocardial Infarction. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, which is completed, enrolled 7,264 participants and was randomized, double-blind, and placebo-controlled.
Colchicine is being studied in a Phase 3 clinical trial with the identifier NCT03048825, titled "Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry." The trial has been completed and enrolled 7,264 patients with ST Elevation Myocardial Infarction and Non ST Elevation Myocardial Infarction across multiple countries.
Colchicine is a distinct drug and is not known to be the same as any other medication under a different name. It is being developed by Boston Scientific Corporation for the treatment of ST Elevation Myocardial Infarction. No alternative names have been associated with this drug in the context of this development program.