Status:
COMPLETED
A Study of Acute Myocardial Infarction Using FDY-5301
Lead Sponsor:
Faraday Pharmaceuticals, Inc.
Conditions:
Acute Myocardial Infarction
STEMI
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart ...
Eligibility Criteria
Inclusion
- 18-80 year old male subjects
- 18 to 80 year old female subjects who are not of child-bearing potential.
- Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads), within 12 hours of symptom onset.
- Written informed consent prior to study participation (either by the subject or a legally authorized representative of the subject)
Exclusion
- Previous myocardial infarction
- Left bundle branch block (LBBB)
- Previous coronary artery bypass graft surgery (CABG)
- Major hemodynamic instability or uncontrolled ventricular arrhythmias
- Known contraindication to CMR
- Patients with known thyroid disease
- Subjects with past or current renal impairment requiring dialysis
- Pregnant or females of child bearing potential
- Body weight \> 120 kg or Body Mass Index (BMI) \> 35 kg/m2
- Use of investigational drugs or devices within 30 days prior to enrollment into the study.
- Life expectancy of less than 1 year due to non-cardiac pathology
- Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03470441
Start Date
October 27 2017
End Date
January 3 2019
Last Update
December 14 2021
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55047
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
3
Budai Irgalmasrendi Kórház
Budapest, Hungary
4
Magyar Honvédség Egészségügyi Központ
Budapest, Hungary