IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo- Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarctio
- Conditions
- myocardial infarctionSTEMI10028593
- Registration Number
- NL-OMON54138
- Lead Sponsor
- Faraday Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of subjects who experience either cardiovascular mortality<br /><br>(defined as deaths which are sudden and due to presumed arrhythmia, or deaths<br /><br>due to presumed or confirmed thromboembolic cerebral vascular accident,<br /><br>presumed or confirmed pulmonary embolism, cardiac rupture, heart failure,<br /><br>recurrent myocardial infarction [e.g., remote or stent thrombosis], and deaths<br /><br>due to procedural efforts to treat these defined cardiac events), or a heart<br /><br>failure event through Month 12.</p><br>
- Secondary Outcome Measures
Name Time Method