Trial · NCT03470441
A Study of Acute Myocardial Infarction Using FDY-5301
NCT03470441, Phase 2, Completed, Faraday Pharmaceuticals, Inc.; results first posted 2021-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Acute Myocardial Infarction Using FDY-5301. Trials, record NCT03470441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03470441
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Acute Myocardial Infarction Using FDY-5301
- NCT number
- NCT03470441
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Faraday Pharmaceuticals, Inc.
- Conditions
- Acute Myocardial Infarction, STEMI
- Interventions
- FDY-5301, Placebo
- First posted
- 2018-03-20
- Last updated
- 2026-01-16
- Results first posted
- 2021-12-14
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arrhythmias of Interest, 48 Hours (Overall) | First 48 hours post-treatment | Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment. |
| Primary | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | 48 hours post-treatment | Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group |
| Primary | Arrhythmias of Interest, 14 Days (Overall) | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) | Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment. |
| Primary | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) | Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group |
| Secondary | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 72 hours post-treatment | Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment |
| Secondary | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 3 months post-treatment | Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment) |
| Secondary | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 72 hours post-treatment | Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment) |
| Secondary | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 3 months post-treatment | Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment) |
| Secondary | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 72 hours post-treatment | Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment |
| Secondary | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 3 months post-treatment | Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arrhythmias of Interest, 48 Hours (Overall) | First 48 hours post-treatment | participants | NUMBER | |
| PRIMARY | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | 48 hours post-treatment | Percentage | NUMBER | |
| PRIMARY | Arrhythmias of Interest, 14 Days (Overall) | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) | participants | NUMBER | |
| PRIMARY | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) | Percentage | NUMBER | |
| SECONDARY | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 72 hours post-treatment | INF/VV (%) | MEDIAN | |
| SECONDARY | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 3 months post-treatment | INF/VV (%) | MEDIAN | |
| SECONDARY | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 72 hours post-treatment | INF/VV (%) | MEDIAN | |
| SECONDARY | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 3 months post-treatment | INF/VV (%) | MEDIAN | |
| SECONDARY | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 72 hours post-treatment | mL/kg/M2 | MEDIAN | |
| SECONDARY | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 3 months post-treatment | mL/kg/M2 | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 Low Dose | Ventricular Fibrillation | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 Intermediate Dose | Ventricular Fibrillation | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 High Dose | Ventricular Fibrillation | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Placebo | Ventricular Fibrillation | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 Low Dose | Sustained Ventricular Tachycardia | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 Intermediate Dose | Sustained Ventricular Tachycardia | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 High Dose | Sustained Ventricular Tachycardia | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Placebo | Sustained Ventricular Tachycardia | 0 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 Low Dose | Non-Sustained Ventricular Tachycardia | 1 | participants | |
| Arrhythmias of Interest, 48 Hours (Overall) | Experimental FDY-5301 Intermediate Dose | Non-Sustained Ventricular Tachycardia | 1 | participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental FDY-5301 Low Dose | 29 | |
| Overall Study | STARTED | Experimental FDY-5301 Intermediate Dose | 31 | |
| Overall Study | STARTED | Experimental FDY-5301 High Dose | 31 | |
| Overall Study | STARTED | Placebo | 29 | |
| Overall Study | COMPLETED | Experimental FDY-5301 Low Dose | 28 | |
| Overall Study | COMPLETED | Experimental FDY-5301 Intermediate Dose | 26 | |
| Overall Study | COMPLETED | Experimental FDY-5301 High Dose | 29 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Experimental FDY-5301 Low Dose | 1 | |
| Overall Study | NOT COMPLETED | Experimental FDY-5301 Intermediate Dose | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ventricular tachycardia | Cardiac disorders | Experimental FDY-5301 Low Dose | 0 | 29 | 0 |
| other | Ventricular tachycardia | Cardiac disorders | Experimental FDY-5301 Intermediate Dose | 2 | 31 | 2 |
| other | Ventricular tachycardia | Cardiac disorders | Experimental FDY-5301 High Dose | 3 | 31 | 3 |
| other | Ventricular tachycardia | Cardiac disorders | Placebo | 1 | 29 | 1 |
| other | Cardiac failure | Cardiac disorders | Experimental FDY-5301 Low Dose | 2 | 29 | 2 |
| other | Cardiac failure | Cardiac disorders | Experimental FDY-5301 Intermediate Dose | 0 | 31 | 0 |
| other | Cardiac failure | Cardiac disorders | Experimental FDY-5301 High Dose | 1 | 31 | 1 |
| other | Cardiac failure | Cardiac disorders | Placebo | 0 | 29 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Experimental FDY-5301 Low Dose | 1 | 29 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Experimental FDY-5301 Intermediate Dose | 0 | 31 | 0 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental FDY-5301 Low Dose | 0 | 29 |
| Total, all-cause mortality | Experimental FDY-5301 Intermediate Dose | 1 | 31 |
| Total, all-cause mortality | Experimental FDY-5301 High Dose | 1 | 31 |
| Total, all-cause mortality | Placebo | 1 | 29 |
| Total, other adverse events | Experimental FDY-5301 Low Dose | 9 | 29 |
| Total, other adverse events | Experimental FDY-5301 Intermediate Dose | 4 | 31 |
| Total, other adverse events | Experimental FDY-5301 High Dose | 9 | 31 |
| Total, other adverse events | Placebo | 18 | 29 |
| Total, serious adverse events | Experimental FDY-5301 Low Dose | 7 | 29 |
| Total, serious adverse events | Experimental FDY-5301 Intermediate Dose | 7 | 31 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34774885 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03470441
GET https://conductscience.org/api/trials/v1/NCT03470441/results?page=2