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NCT03772743: FIRE
Functional Assessment in Elderly MI Patients With Multivessel Disease
NA trial testing Culprit-only revascularization in Myocardial Infarction in 1,445 participants. Participants enrolled and being followed up; not accepting new ones.
30 October 2022
Quick facts
| Lead sponsor | Consorzio Futuro in Ricerca |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,445 |
| Start date | 15 July 2019 |
| Primary completion | 30 October 2022 |
| Estimated completion | 3 October 2026 |
| Sites | 37 locations across Italy, Spain, Poland |
Drugs / interventions tested
- Culprit-only revascularization
- Complete functionally-guided revascularization
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
Sponsor
Consorzio Futuro in Ricerca
Who can join
75 and older, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Elderly patients presenting with myocardial infarction (MI) and multivessel disease are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome. The actual real-life standard of care is, in the best of the cases, culprit only revascularization. However, real-life registries show that outcome of MI elderly patients treated with this strategy is far from being optimal with at least a 15% rate of cardiac death or myocardial infarction at 1 year. To date, studies on this population have been focused on devices (bare metal stent vs biodegradable drug eluting stent) or on dual antiplatelet regimen (long vs short) and no study was focused on evaluating if complete revascularization is able to improve the prognosis in these patients. The contemporary complete revascularization is represented by a functionally-driven revascularization that recently showed to significantly reduce myocardial infarction rate and outperformed an angio-complete revascularization. Thus, our hypothesis is that a functionally-driven complete revascularization in elderly patients with MI and multivessel disease may improve prognosis compared to the actual standard of care in these patients, namely culprit only revascularization. Being a "strategy" trial, we identified the patient-oriented composite endpoint (POCE) as primary outcome of interest (all cause death, any MI, any stroke, any revascularization). Several pre-specified substudies have been planned. A detailed list of the substudies is available in the website of the trial (http://www.thefiretrial.com)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03772743
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients · recruiting
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Other Consorzio Futuro in Ricerca trials
Trials by the same sponsor.
- NCT07193693 — Barriers Limiting OCT Penetration in Clinical Practice · recruiting
- NCT06025994 — Standardizing the Management of Patients With Coronary Microvascular Dysfunction · NA · active not recruiting
- NCT05174572 — IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03772743 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Consorzio Futuro in Ricerca
- Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03772743.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing