What side effects are associated with this type of intervention?

Common treatments for heart attacks, especially in anterior STEMI patients undergoing pPCI, include thrombolytic therapy, antiplatelet agents, and anticoagulants. Thrombolytic therapy, such as APSAC, can significantly reduce mortality but may cause bleeding complications. Antiplatelet agents like aspirin and ticagrelor reduce the risk of further cardiovascular events but can increase the risk of bleeding, including gastrointestinal and intracranial hemorrhages. Anticoagulants also help prevent clot formation but carry a similar risk of bleeding. Additionally, some patients may experience dyspnea or minor bleeding with ticagrelor.

What prior FDA approvals exist?

The FDA has approved several treatments for heart attacks, particularly for patients with STEMI undergoing pPCI. Thrombolytic agents like anisoylated plasminogen streptokinase activator complex (APSAC) have shown significant reductions in mortality when administered early after myocardial infarction. Antiplatelet therapies, including aspirin and P2Y12 inhibitors like clopidogrel, are also standard treatments to prevent clot formation and improve outcomes. Additionally, anticoagulants such as heparin are used during pPCI to reduce the risk of further cardiac events. These treatments collectively aim to reduce cardiovascular mortality and acute heart failure events, similar to the goals of FDY-5301.

What other types of research exist?

Promising novel alternatives to FDY-5301 for heart attack patients include protease-activated receptor 1 (PAR-1) antagonists like vorapaxar, which reduce thrombotic events, and dual antiplatelet therapy (DAPT) with ticagrelor, which has shown significant reductions in major adverse cardiovascular events (MACE) and major adverse limb events (MALE).

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FDY-5301 for Heart Attack (IOCYTE AMI-3 Trial)

Phase 3

Waitlist Available

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

Must not have

Renal disease requiring dialysis

Life expectancy of less than 1 year due to non-cardiac pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through month 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug called FDY-5301 to see if it can help people who have had a severe heart attack. It focuses on patients undergoing a procedure to open blocked arteries and aims to improve their recovery and reduce complications.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a heart procedure within 6 hours of my first chest pain.

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I had a heart attack in the front part of my heart with specific ECG changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis for kidney failure.

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My doctor expects I have less than 1 year to live due to a non-heart related condition.

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I am not pregnant or breastfeeding, and I have a negative pregnancy test.

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My weight is over 309 lbs.

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I have a thyroid condition or am on thyroid medication.

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I received clot-dissolving medication for my heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and through month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of either cardiovascular mortality or heart failure

Secondary study objectives

All-cause mortality or acute heart failure

Cardiovascular events

Other non-fatal cardiovascular morbidity

+1 more

Side effects data

From 2019 Phase 2 trial • 120 Patients • NCT03470441

Constipation

Cardiac failure

Haematoma

Atrial fibrillation

Acute myocardial infarction

Liver function test abnormal

Coronary artery dissection

Vascular stent thrombosis

Cardiac ventricular thrombosis

Ischaemic stroke

Chest pain

Colitis

Gastroduodenitis

Delirium

Diarrhoea

Dizziness

Coronary artery disease

100%

80%

60%

40%

20%

Study treatment Arm

Experimental FDY-5301 Low Dose

Experimental FDY-5301 Intermediate Dose

Experimental FDY-5301 High Dose

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart attacks include antiplatelet agents, anticoagulants, thrombolytics, and beta-blockers. Antiplatelet agents like aspirin and clopidogrel prevent platelets from clumping, reducing clot formation. Anticoagulants such as heparin inhibit clotting factors to prevent new clots. Thrombolytics like tissue plasminogen activator (tPA) dissolve existing clots to restore blood flow. Beta-blockers reduce heart rate and blood pressure, decreasing the heart's oxygen demand. These treatments are crucial for heart attack patients as they help restore and maintain blood flow to the heart, reduce the risk of further cardiac events, and improve survival.