Study of Modified Anti-Platelet Therapy with Prasugrel, Ticagrelor, and Clopidogrel in Heart Attack Patients Undergoing Complete Revascularization

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What is this study about?

This clinical trial is focused on patients who have experienced a heart attack, medically known as Acute Myocardial Infarction. The study aims to evaluate a modified treatment approach using anti-platelet therapy, which involves medications that help prevent blood clots. The medications being studied include Efient (containing prasugrel), Brilique (containing ticagrelor, also known as AZD6140), Plavix (containing clopidogrel), and Aspirine Protect (containing acetylsalicylic acid, commonly known as aspirin). These medications are used to prevent blood platelets from clumping together, which can help keep blood vessels open after a heart attack.

The purpose of the study is to assess the effectiveness of this modified anti-platelet therapy in patients who have undergone a procedure called complete revascularization. This procedure involves treating not only the blockage that caused the heart attack but also any other significant blockages in the heart’s blood vessels. The study will also involve the use of a Firehawk drug-eluting stent, a small tube inserted into the blood vessels to keep them open, which is coated with a low dose of a drug called rapamycin to help prevent further blockages.

Participants in the study will receive one of the anti-platelet medications or a placebo and will be monitored over a period of time to evaluate the occurrence of any adverse events, such as heart-related complications or bleeding. The study will last for up to 52 weeks, during which the safety and effectiveness of the treatment will be closely observed. The main goal is to determine if the modified therapy is as effective as current treatments in preventing serious health events in patients who have had a heart attack.

1 joining the study

Participation begins after providing written consent and meeting specific health criteria, such as having experienced a heart attack and undergoing a procedure to open blocked heart vessels within the last 7 days.

2 initial treatment phase

Receive a Firehawk drug-eluting stent, a small tube placed in the heart’s blood vessels to keep them open. This stent releases a low dose of a drug called rapamycin to prevent the vessels from narrowing again.

3 medication regimen

Begin a modified anti-platelet therapy to prevent blood clots. This includes taking the following medications orally:

Efient (prasugrel) 10 mg film-coated tablets.

Brilique (ticagrelor) 90 mg film-coated tablets.

Plavix (clopidogrel) 75 mg film-coated tablets.

Aspirine Protect (acetylsalicylic acid) 100 mg gastro-resistant tablets.

4 follow-up and monitoring

Regular follow-up appointments to monitor health and the effectiveness of the treatment. This includes checking for any adverse events such as heart-related issues or bleeding.

5 evaluation of outcomes

The primary goal is to assess the safety and effectiveness of the treatment in preventing serious health events over a period of 11 months after starting the study.

6 completion of the study

The study is expected to conclude by April 2025, with final evaluations of health outcomes and any side effects experienced during the trial.

Who Can Join the Study?

The patient must have had a type of heart attack called Acute Myocardial Infarction.
The patient must have a positive test for Troponin, which is a protein released when the heart muscle is damaged, indicating a heart attack.
The patient must need an early invasive treatment called PCI (Percutaneous Coronary Intervention), which is a procedure to open blocked heart arteries.
The PCI must have been done within the last 7 days.
The patient must be eligible for the specific antiplatelet treatments used in the study. Antiplatelet treatments help prevent blood clots.
The patient must provide written informed consent, meaning they agree to participate in the study after understanding what it involves.
The patient must meet certain angiographic criteria, which are conditions related to the imaging of blood vessels. This includes successful treatment of the heart’s native arteries, with specific size requirements for the arteries and stents used.
The patient must have had complete revascularization, meaning all significant blockages were treated, either during the initial procedure or within 7 days after it.
The patient must be between the ages of 18 and 64.
Both male and female patients can participate.
The study does not include vulnerable populations, which means it does not involve groups that might need special protection, like children or those unable to consent.

Who Cannot Join the Study?

Patients who have had a recent Acute Myocardial Infarction (a heart attack) may not be eligible.
Individuals who are not clinically stable or have high complexity in their heart condition might be excluded.
Participants who are not within the specified age range for the study may be excluded.
People who are part of a vulnerable population, such as those unable to give consent, are not eligible.
Individuals who do not meet the specific health criteria set by the study may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Azienda Ospedaliera di Padova	Padua	Italy
Haga Hospital	Hague	The Netherlands
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Hhlkjxbl Uhvvansyudvbw Dk Lj Pwpyslqf	Madrid	Spain
Okzkmryp Gucwrtof Ptjzu Ia	Ragusa	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	25.03.2021
Spain	Not recruiting	25.03.2021
The Netherlands	Not recruiting	25.03.2021

Trial locations

Investigated drugs:

Anti-Platelet Therapy is used to prevent blood cells called platelets from clumping together and forming clots. This therapy is important for patients who have had a heart attack, as it helps to keep the blood flowing smoothly through the arteries and reduces the risk of another heart attack.

Rapamycin DES Firehawk is a type of drug-eluting stent that releases a medication called rapamycin. This stent is placed in the arteries to keep them open after a procedure to restore blood flow. The rapamycin helps to prevent the artery from becoming blocked again by reducing the growth of scar tissue.

Investigated diseases:

Acute myocardial infarction

Acute Myocardial Infarction – This condition, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. The blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, which can obstruct the flow of blood. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression of the disease can lead to complications such as heart failure or arrhythmias if not managed promptly.

Trial ID:

2024-519854-35-00

Protocol code:

SFHI01

NCT ID:

NCT04753749

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Modified Anti-Platelet Therapy with Prasugrel, Ticagrelor, and Clopidogrel in Heart Attack Patients Undergoing Complete Revascularization

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?