Study on the Effects of Ticagrelor and Acetylsalicylic Acid in Patients with Coronary Artery Disease Undergoing CABG Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients with coronary artery disease, a condition where the blood vessels supplying the heart become narrowed or blocked. The study will explore the use of a medication called ticagrelor, which is often used to prevent blood clots, in combination with acetylsalicylic acid (commonly known as aspirin), compared to using aspirin alone. The trial is named “The One-Month DAPT with Ticagrelor In CABG Patients Trial (ODIN).” The purpose of the study is to compare the effects of these treatments on the occurrence of heart-related events and the success of heart bypass surgery over a period of one year.

Participants in the study will be patients undergoing a type of heart surgery known as CABG (Coronary Artery Bypass Grafting), which is performed to improve blood flow to the heart. The study will last for one month, during which participants will receive either the combination of ticagrelor and aspirin or aspirin alone. The researchers will then monitor the participants for one year to assess the incidence of heart-related events such as heart attacks, strokes, and any issues with the grafts used in the surgery.

The study aims to provide valuable information on whether the combination of ticagrelor and aspirin is more effective than aspirin alone in reducing the risk of heart-related events after CABG surgery. This information could help improve treatment strategies for patients with coronary artery disease undergoing this type of surgery. Participants will be followed up for a total of five years to gather long-term data on their health and quality of life.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), undergoing elective first-time coronary artery bypass grafting (CABG) with at least one saphenous vein graft, and having chronic coronary disease.

Consent is required to participate and comply with study procedures, including follow-up for at least 5 years.

2 medication administration

The study involves taking medications orally. The medications include ticagrelor and acetylsalicylic acid (ASA).

Ticagrelor is administered as 90 mg film-coated tablets, and ASA is provided in various forms such as 100 mg gastro-resistant tablets and 75 mg tablets.

The treatment duration with ticagrelor in addition to ASA is for 1 month.

3 monitoring and follow-up

The primary goal is to assess the effect of ticagrelor in addition to ASA versus ASA alone on the 1-year incidence of ischemic events and graft failure.

Monitoring includes evaluating the time to death, stroke, heart attack, repeat revascularization, and any graft failure at 1 year.

Secondary assessments include the same events plus bleeding and quality of life scores over 5 years.

4 completion of study

The study is expected to conclude by March 30, 2030.

Participants are followed up for at least 5 years to gather comprehensive data on the long-term effects of the treatment.

Who Can Join the Study?

Must be 18 years old or older.
Scheduled for a first-time elective CABG. CABG stands for Coronary Artery Bypass Grafting, which is a type of heart surgery.
Use of at least one saphenous vein graft during the surgery. A saphenous vein graft is a vein taken from the leg to help improve blood flow to the heart.
Must be able to sign informed consent. This means you understand the study and agree to participate.
Must be able to follow all study procedures and attend follow-up visits for at least 5 years.
Have chronic coronary disease. This is a long-term condition affecting the blood vessels of the heart.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medications.
Patients with active bleeding or a high risk of bleeding.
Patients who have had a stroke or a mini-stroke (also known as a transient ischemic attack) in the past 6 months.
Patients with severe liver disease.
Patients who are currently taking medications that strongly interact with the study drugs.
Patients with a history of drug or alcohol abuse within the past year.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any other medical 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
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Medical University Of Graz	Graz	Austria
Medizinische Universitaet Innsbruck	Innsbruck	Austria

Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Robert Bosch Gesellschaft fuer medizinische Forschung mbH	Stuttgart	Germany
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen	Munich	Germany
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Jkfgtcom Kcbwik Uxnlaehagv	Linz	Austria
Ukmqvmgsucduzixstmran Ewqlv Aeb	Essen	Germany
Ubibdktqmhyxaxmmefwww Ddfupwcmqlg Aez	Duesseldorf	Germany
Utiiaheyxqkmgmutathcv Wucxtizvh Awh	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.09.2024
Germany	Recruiting	01.09.2024
Sweden	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Ticagrelor is a medication used to prevent blood clots in patients who have had a heart attack or are undergoing certain heart procedures. In this trial, it is being tested to see if it can reduce the risk of ischemic events and graft failure in patients who have had coronary artery bypass grafting (CABG) surgery.

ASA, also known as aspirin, is a common medication used to reduce pain, fever, or inflammation. It is also used to prevent blood clots in patients with heart conditions. In this trial, ASA is being used alone and in combination with ticagrelor to see its effectiveness in preventing complications after CABG surgery.

Investigated diseases:

Coronary artery disease

Coronary Artery Disease – This condition occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, primarily 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 the blood flow becomes severely restricted or blocked, it can result in a heart attack. The progression of coronary artery disease can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a more gradual development.

Trial ID:

2023-506613-22-00

Protocol code:

ODIN

NCT ID:

NCT05997693

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Ticagrelor and Acetylsalicylic Acid in Patients with Coronary Artery Disease Undergoing CABG Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?