A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of IV FDY-5301 in patients with a myocardial infarction (STEMI)

Phase 1

Conditions: Anterior ST-ElevationMyocardial Infarction
MedDRA version: 20.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2021-001924-16-HU

Lead Sponsor: Faraday Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2300

Inclusion Criteria

1. Age = 18 years
2. Anterior STEMI, based on: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and
ECG criteria:
• men > 40 years: = 2 mm of ST elevation in V2 and V3
• men = 40 years: = 2.5 mm of ST elevation in V2 and V3
• women = 1.5 mm of ST elevation in V2 and V3
3. Planned primary PCI to occur = 6 hours of onset of first symptoms of myocardial ischemia
4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1800

Exclusion Criteria

1. Life expectancy of less than 1 year due to non-cardiac pathology
2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
3. Known allergy to iodine
4. Renal disease requiring dialysis
5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
6. Body weight >140 kg (or 309 lbs)
7. Use of thrombolytic therapy as treatment for the index STEMI event
8. Use of investigational drugs or devices 30 days prior to randomization
9. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI.;Secondary Objective: To assess the effect of FDY-5301 on other clinical outcomes such as all-cause mortality and cardiovascular outcomes in subjects with an anterior STEMI undergoing pPCI;Primary end point(s): The proportion of subjects who experience either cardiovascular mortality (defined as deaths which are sudden and due to presumed arrhythmia, or deaths due to presumed or confirmed thromboembolic CVA, presumed or confirmed pulmonary embolism, cardiac rupture, heart failure, recurrent myocardial infarction [e.g., remote or stent thrombosis], and deaths due to procedural efforts to treat these defined cardiac events), or a heart failure event through Month 12;Timepoint(s) of evaluation of this end point: through month 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •The proportion of subjects who experience either all-cause mortality or a heart failure event through Month 12 <br>•The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through Month 12<br>•The proportion of subjects who experience specified non-fatal cardiovascular events of thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia through Month 12 <br>•Serum troponin T at Day 3<br>;Timepoint(s) of evaluation of this end point: see E.5.2 for evaluation timing

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