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FDY-5301 for Heart Attack (IOCYTE AMI-3 Trial)
Phase 3
Recruiting
Research Sponsored by Faraday Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Planned primary PCI to occur ≤ 6 hours of onset of first symptoms of myocardial ischemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through month 12
Awards & highlights
IOCYTE AMI-3 Trial Summary
This trial tests a new drug to see if it can reduce heart failure and death in people who have had a heart attack.
Who is the study for?
This trial is for adults over 18 with a specific type of heart attack called anterior STEMI, who can get treatment within 6 hours. It's not for those with life-threatening non-cardiac issues, pregnant or breastfeeding women, people on recent investigational drugs, thyroid disease patients, iodine allergy sufferers, individuals on dialysis, or anyone over 309 lbs.Check my eligibility
What is being tested?
The study tests if FDY-5301 reduces death from heart problems and acute heart failure in patients having a procedure to open blocked arteries after a severe type of heart attack. Participants will either receive FDY-5301 or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Specific side effects of FDY-5301 are not listed here but could include reactions related to the cardiovascular system given the nature of the drug and patient population. Placebos typically have no active ingredients but can cause side effects due to psychological factors.
IOCYTE AMI-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for a heart procedure within 6 hours of my first chest pain.
Select...
I had a heart attack in the front part of my heart with specific ECG changes.
IOCYTE AMI-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of either cardiovascular mortality or acute heart failure
Secondary outcome measures
All-cause mortality or acute heart failure
Cardiovascular events
Other non-fatal cardiovascular morbidity
+1 moreSide effects data
From 2019 Phase 2 trial • 120 Patients • NCT034704417%
Atrial fibrillation
7%
Cardiac failure
7%
Constipation
7%
Haematoma
3%
Gastroduodenitis
3%
Acute myocardial infarction
3%
Cardiac ventricular thrombosis
3%
Chest pain
3%
Liver function test abnormal
3%
Coronary artery dissection
3%
Coronary artery disease
3%
Vascular stent thrombosis
3%
Ischaemic stroke
3%
Dizziness
3%
Delirium
3%
Colitis
3%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental FDY-5301 Low Dose
Experimental FDY-5301 High Dose
Experimental FDY-5301 Intermediate Dose
Placebo
IOCYTE AMI-3 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FDY-5301Experimental Treatment1 Intervention
FDY-5301 will be administered as a single IV bolus injection.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (normal saline) will be administered as a single IV bolus injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDY-5301
2017
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Faraday Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am on dialysis for kidney failure.I am scheduled for a heart procedure within 6 hours of my first chest pain.My doctor expects I have less than 1 year to live due to a non-heart related condition.I am not pregnant or breastfeeding, and I have a negative pregnancy test.My weight is over 309 lbs.I have a thyroid condition or am on thyroid medication.I received clot-dissolving medication for my heart attack.You are allergic to iodine.I had a heart attack in the front part of my heart with specific ECG changes.
Research Study Groups:
This trial has the following groups:- Group 1: FDY-5301
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is FDY-5301 dangerous for human beings?
"There is existing clinical evidence to support the safety of FDY-5301, as this is a Phase 3 trial."
Answered by AI
Are patients currently being recruited to participate in this trial?
"Yes, this study is still recruiting patients, as reflected on clinicaltrials.gov. The listing was created on 5/2/2022 and was last updated 29 days ago on 9/29/2022."
Answered by AI
How many individuals are eligible for this research program?
"The data on clinicaltrials.gov indicate that this clinical trial is actively recruiting participants. The trial was originally posted on 5/2/2022 and was last updated on 9/29/2022. The trial is searching for 2300 participants across 10 locations."
Answered by AI
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