This study has been transitioned to CTIS with ID 2024-514372-40-00 check the CTIS register for the current data. Primary objective: To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 cerebral vascular accident,
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.
Secondary outcome
Secondary Endpoints:
- The proportion of subjects who experience either all-cause mortality or a
heart failure event through Month 12
- The total number of cardiovascular events defined as cardiovascular mortality
and heart failure events through Month 12
- The proportion of subjects who experience a composite the following 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 requiring intervention
(e.g., ventricular fibrillation, sustained ventricular tachycardia, or
bradyarrhythmia requiring intervention) through Month 12
- Serum troponin T at Day 3
Exploratory Endpoints:
Individual adverse cardiovascular event outcomes will be evaluated as follows:
- Non-fatal thromboembolic CVA through Month 12
- Non-fatal ventricular aneurysm/hemorrhage through Month 12
- Non-fatal recurrent myocardial infarction (e.g., remote or stent thrombosis)
through Month 12
- Persistent requiring intervention (e.g., ventricular fibrillation, sustained
ventricular tachycardia, or bradyarrhythmia requiring intervention) arrhythmia
through Month 12
- Heart failure managed with initiation or intensification of oral treatment
through Month 12
- The proportion of subjects who experience all-cause mortality through Month
12
Background summary
The first line of therapy for acute ST-elevation myocardial infarction (STEMI)
includes coronary artery reperfusion by mechanical means during primary
percutaneous coronary intervention (pPCI). While clearly effective, it does not
address the issue of reperfusion injury, a secondary damage that occurs
immediately due to the reoxygenation of the previously ischemic myocardial
tissue and contributes to overall final infarct size (IS). Even though pPCI has
dramatically improved the survival rate, the goal of developing FDY-5301 in
acute myocardial infarction (AMI) is to further improve cardiovascular outcomes
such as all-cause mortality, cerebral vascular accident (CVA), recurrent
myocardial infarction (e.g., remote or stent thrombosis), and persistent
arrhythmia after AMI.
Study objective
This study has been transitioned to CTIS with ID 2024-514372-40-00 check the CTIS register for the current data.
Primary 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.
Study design
Randomized, Double-Blind, Placebo- Controlled Study.
Intervention
FDY-5301 (2 mg/kg) will be administered as a single IV bolus injection or
Placebo (normal saline) will be administered as a single IV bolus injection.
Placebo will be volume-matched and indistinguishable from FDY-5301.
Study burden and risks
FDY-5301 has been tested in approximately 140 study participants, including a
study of 91 STEMI participants who received FDY-5301, and no known clinically
significant side effects related to FDY-5301 were reported. These study
participants received a single IV dose of FDY-5301 at doses that were either
below, the same as, or above what is being given for this study.
The following theoretical side effects can occur:
- Over or under production of the thyroid hormone. Overproduction can cause
symptoms such as jitteriness, feeling warm, or a fast pulse rate.
Underproduction can cause symptoms such as feeling cold, tiredness,
constipation, hair loss, or a slow heart rate.
- Too much iodide could possibly cause gastrointestinal (gut) irritation and
bleeding.
1616 Eastlake Ave E Suite 560
Seattle Washington, 98102
US
1616 Eastlake Ave E Suite 560
Seattle Washington, 98102
US
Listed location countries
Age
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
Electrocardiogram (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 persistent symptoms that
caused the patient to pursue medical care for myocardial infarction.
4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
approved consent obtained for study participation
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 or the excipient of the investigational product
(sodium chloride)
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 within 30 days or 5 half-lives whichever is
longer, prior to randomization or the use of investigational devices within 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514372-40-00 |
| EudraCT | EUCTR2021-001924-16-NL |
| ClinicalTrials.gov | NCT04837001 |
| CCMO | NL79392.091.22 |