Study on Reduced Antiplatelet Therapy with Acetylsalicylic Acid and Clopidogrel for Patients with Coronary Artery Disease After Stent Implantation

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What is this study about?

This clinical trial is focused on patients with Coronary Artery Disease, a condition where the blood vessels supplying the heart become narrowed or blocked. The study is investigating the effects of different antiplatelet medications, which help prevent blood clots. The medications being studied include Acetylsalicylic Acid (commonly known as aspirin), Clopidogrel, Ticagrelor (also known by the code name AZD6140), and Prasugrel. These medications are used to reduce the risk of heart attacks and other heart-related issues by preventing platelets in the blood from sticking together.

The purpose of the study is to evaluate the outcomes of using a reduced antiplatelet therapy after the implantation of an Angiolite stent, a small tube placed in the coronary arteries to keep them open. The study will compare the effects of a standard dual antiplatelet therapy (using two medications) with an abbreviated, or shortened, therapy. Participants will be randomly assigned to receive either the standard or the abbreviated therapy. The study will last for up to 12 months, during which the rate of heart-related complications and bleeding events will be monitored.

Participants will take the medications orally, meaning they will swallow them in pill form. The study aims to determine if the abbreviated therapy is as effective as the standard therapy in preventing heart-related issues while also reducing the risk of bleeding. This research is important for understanding how to best manage treatment for patients with coronary artery disease who have received a stent.

1 joining the study

Upon joining the study, eligibility is confirmed based on age and the presence of coronary artery disease. Consent is required to participate.

2 initial assessment

An initial assessment is conducted to evaluate the condition of the coronary arteries. This includes identifying any stenosis, which is a narrowing of the arteries, that is 50% or more.

3 stent implantation

A stent, either an angiolite or Xience, is implanted in the affected coronary artery to help keep it open. This procedure is necessary for patients with significant artery narrowing.

4 medication regimen

After stent implantation, a dual antiplatelet therapy (DAPT) is initiated. This involves taking two types of medications orally to prevent blood clots.

The medications include acetylsalicylic acid and either clopidogrel, ticagrelor, or prasugrel. The specific combination and dosage depend on the group assigned within the study.

5 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor the patient’s health and the effectiveness of the stent and medication.

The primary focus is on observing any target lesion failure, which includes cardiovascular death, myocardial infarction, or the need for further intervention at the stent site.

6 evaluation of outcomes

At the 1-year mark, the study evaluates the rate of target lesion failure and any clinically relevant bleeding events.

The outcomes help determine the effectiveness of the abbreviated antiplatelet therapy compared to the standard regimen.

Who Can Join the Study?

  • Must be between the ages of 18 and 94 years old.
  • Must have one or more narrowed areas in the heart’s blood vessels, known as coronary artery stenosis, where the narrowing is 50% or more. This can be in a natural heart artery or in a bypass vessel used in previous heart surgery. The blood vessel should be at least 2.00 mm wide. There is no limit on the number of narrowed areas, the number of blood vessels affected, or the length of the narrowed area.
  • Must be able to understand the study details and agree to participate by signing a consent form.

Who Cannot Join the Study?

  • Patients who have a known allergy or sensitivity to the materials used in the stents.
  • Patients who are unable to take medications that prevent blood clots, known as antiplatelet therapy.
  • Patients with a history of bleeding disorders, which means they bleed more easily than normal.
  • Patients who have had a heart attack or stroke within the last month.
  • Patients with severe liver or kidney disease, which affects how the body processes medications.
  • Patients who are pregnant or breastfeeding, as the effects on the baby are not known.
  • Patients who are participating in another clinical trial, as this could affect the results.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital Universitario Juan Ramon Jimenez Huelva Spain
Hospital Universitario De Leon Leon Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
AZ Turnhout Turnhout Belgium
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Unviersitario Miguel Servet Zaragoza Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
CHC MontLegia Liege Belgium
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital San Pedro De Alcantara Caceres Spain
Hospital Universitario Torrecardenas Almeria Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
AZ Delta uw Ziekenhuis Campus Rumbeke, campus Brugsesteenweg Roeselare Roeselare Belgium
Hartcentrum OLV Aalst Aalst Germany
Ziekenhuis Oost-Limburg Genk Genk Germany
CHU de Toulouse – Hôpital Pierre-Paul Riquet Toulouse France
Hospital Universitario Virgen De La Victoria Malaga Spain
Imelda Hospital Bonheiden Bonheiden Belgium
Hluopjlu Ujpqfosgnaagv Rrcnhoji Dv Mdbctd Malaga Spain
Clk Mgub Uyelhnfaph Ckjztd Mons Belgium
Hq Mzaum Cdcek Charleroi Belgium
Hfrduaz Javmqv Crhymcd Mjntd Massy France
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Hbkhwxxq Dz Lb Shfhv Ckhg I Sfty Psd Barcelona Spain
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Ckdamgsg Hskqxpiboxxt Ukihfueamhgca Di Vlpw Vigo Spain
Huwdixmx Uqebiywutgjue Hfdywaah Tnkyu y Pcayee Iwbyvgxj Ccpott dpyluiywyrbultpwu (qrpv Badalona Spain
Hpomkafm Vfai dylzpfox Barcelona Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
13.10.2023
France France
Not recruiting
13.10.2023
Spain Spain
Not recruiting
13.10.2023

Trial locations

Angiolite Stent is a medical device used in the trial to help keep blood vessels open in patients with certain heart conditions. It is being tested to see if it is as effective as another type of stent in preventing complications like blockages in the blood vessels.

Xience Stent is another type of stent used in the trial. It serves a similar purpose as the Angiolite Stent, helping to keep blood vessels open. The trial aims to compare its effectiveness with the Angiolite Stent in preventing issues such as blockages.

Dual Antiplatelet Therapy (DAPT) is a treatment involving two medications that help prevent blood clots. This therapy is used in patients who have had stents placed in their blood vessels. The trial is comparing the standard duration of this therapy with a shorter, abbreviated version to see which is more effective in reducing bleeding risks while still preventing clots.

Investigated diseases:

Coronary Artery Disease – This condition occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, often due to the buildup of cholesterol and other substances, known as plaque, on the artery walls. Over time, this plaque can harden or rupture, leading to narrowed or blocked arteries, which reduces blood flow to the heart. As the disease progresses, it can cause chest pain, shortness of breath, or other symptoms, especially during physical activity or stress. If a plaque ruptures, it can lead to a heart attack, which is a sudden blockage of blood flow to the heart muscle. The progression of coronary artery disease can vary, with some individuals experiencing symptoms early on, while others may not notice any signs until a significant blockage occurs. Regular monitoring and lifestyle changes can help manage the condition and slow its progression.

Trial ID:
2023-507015-35-00
NCT ID:
NCT05952206
Trial Phase:
Therapeutic confirmatory (Phase III)

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