A study looking at the effects of a new drug (FDY-501) in patients who have had a heart attack

Phase 1

• Conditions: Acute Myocardial Infarction; MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000047-41-PL
• Lead Sponsor: Faraday Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

1. 18-80 year old male subjects
2. 18 to 80 year old female subjects who are not of childbearing potential
3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the Jpoint 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
4. Assent/Informed consent to 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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Previous myocardial infarction
2. Left bundle branch block (LBBB)
3. Previous coronary artery bypass graft surgery (CABG)
4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
5. Known contraindication to CMR (e.g. pacemaker)
6. Patients with known thyroid disease, or known allergy to iodide
7. Subjects with past or current renal impairment requiring dialysis
8. Pregnant or females of childbearing potential
9. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
10. Use of investigational drugs or devices within 30 days prior to enrollment into the study
11. Life expectancy of less than 1 year due to non-cardiac pathology
12. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified