Study on the Effectiveness of Clopidogrel, Prasugrel, and Ticagrelor in Patients with Coronary Acute Syndrome Using VerifyNow Device

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What is this study about?

This clinical trial is focused on studying treatments for Cardiovascular Diseases, specifically in patients with a condition known as Acute Coronary Syndrome (ACS). ACS is a term used for situations where the blood supplied to the heart muscle is suddenly blocked. The study involves three medications: Brilique (ticagrelor), Efient (prasugrel), and Plavix (clopidogrel). These medications are known as antiplatelet agents, which help prevent blood clots by stopping platelets, a type of blood cell, from sticking together.

The purpose of the study is to determine if switching from the more powerful antiplatelet agents, prasugrel and ticagrelor, to clopidogrel, with guidance from a device called VerifyNow, can have a positive effect on treating ACS. The VerifyNow device measures how well platelets are being inhibited, or stopped, from forming clots. Participants in the study will take these medications in the form of film-coated tablets, which are taken orally, meaning they are swallowed. The study will last for up to 12 months, during which time the effects of the medication switch will be monitored.

Throughout the study, researchers will look at the occurrence of certain heart-related events, such as heart attacks, strokes, and bleeding incidents. These are referred to as Net Adverse Cardiac Events (NACE). The study aims to see if the change in medication can reduce these events over a 12-month period. The results will help determine the best approach to using these medications for people with ACS.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be 18 years or older, understand the study, and have provided written consent.

Participants should have experienced an Acute Coronary Syndrome (ACS) and undergone a procedure called Percutaneous Coronary Intervention (PCI) with a specific type of stent. They should be discharged on a combination of medications including Acetylsalicylic Acid and either Ticagrelor or Prasugrel.

2 initial treatment phase

Participants begin treatment with either Brilique (Ticagrelor) 90 mg or Efient (Prasugrel) 10 mg, both taken orally as film-coated tablets.

The treatment aims to manage platelet activity in the blood, which is crucial for patients with cardiovascular conditions.

3 treatment adjustment

The study uses a device called VerifyNow® to measure platelet aggregation. This helps determine if a switch to Plavix (Clopidogrel) 75 mg, also taken orally as a film-coated tablet, is beneficial.

The goal is to optimize treatment by potentially reducing the strength of the medication while maintaining effectiveness.

4 monitoring and follow-up

Participants are monitored for any adverse cardiac events, such as heart attacks or strokes, over a 12-month period.

The study also tracks any bleeding events and other health outcomes related to the heart and blood vessels.

5 completion of study

The study is expected to conclude by December 2025. At this point, all data regarding the incidence of cardiac events and other health outcomes will be analyzed.

The results will help determine the effectiveness of adjusting medication based on platelet activity measurements.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must be able to understand the nature of the study.
Patients must have provided written informed consent, which means they agree to participate after understanding the study details.
Patients must have Acute Coronary Syndrome (ACS), a condition where the heart doesn’t get enough blood.
Patients must have undergone Percutaneous Coronary Intervention (PCI), a procedure to open blocked heart arteries, during their hospital stay.
Patients must have received an absorbable polymer stent, a small tube placed in the artery to keep it open.
Patients must have been discharged on double antiplatelet therapy, which means taking two medications to prevent blood clots: Acetylsalicylic Acid (Aspirin) and either Ticagrelor or Prasugrel.

Who Cannot Join the Study?

Patients with certain types of cardiovascular diseases cannot participate. Cardiovascular diseases are conditions that affect the heart and blood vessels.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital De Galdakao Usansolo	Galdakao	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Hsngsbml Urgrvfrpqdxst Myngjxa Dj Vididoeiqq	Santander	Spain
Fzrspoqcv Pqco Lb Ivhbmaltdqqbp Bqqrovfye Dbx Hweexpea Uramznusqfozq Ld Ppx	Madrid	Spain
Hrrgsjku Vymx deegpxmj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.07.2021

Trial locations

Investigated drugs:

Prasugrel is a medication used to prevent blood clots in people with acute coronary syndrome (ACS). It works by making the blood less sticky, which helps to reduce the risk of heart attacks or strokes.

Ticagrelor is another medication that helps prevent blood clots in patients with ACS. It works similarly to prasugrel by reducing the stickiness of the blood, thereby lowering the chance of heart-related complications.

Clopidogrel is a medication used to prevent blood clots in people with heart conditions. In this trial, it is used as a less powerful alternative to prasugrel and ticagrelor, with its use guided by a special device to measure platelet activity.

Investigated diseases:

Acute coronary syndrome

Cardiovascular Diseases – These are a group of disorders affecting the heart and blood vessels. They can include conditions such as coronary artery disease, which involves the narrowing or blockage of the coronary arteries, and can lead to chest pain or heart attacks. Another example is heart failure, where the heart is unable to pump blood effectively, causing symptoms like shortness of breath and fatigue. Cardiovascular diseases can also involve arrhythmias, which are irregular heartbeats that may cause palpitations or dizziness. Over time, these conditions can lead to complications such as heart attacks or strokes. They often progress due to factors like high blood pressure, high cholesterol, smoking, and a sedentary lifestyle.

Trial ID:

2024-512436-29-00

Protocol code:

EPIC17

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effectiveness of Clopidogrel, Prasugrel, and Ticagrelor in Patients with Coronary Acute Syndrome Using VerifyNow Device

What is this study about?

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