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Acetylsalicylic Acid Ph. Eur.

This article discusses a clinical trial investigating the use of Acetylsalicylic Acid Ph. Eur. (commonly known as aspirin) in patients with coronary artery disease who are undergoing coronary artery bypass graft (CABG) surgery. The trial, named ODIN (The One-Month DAPT with Ticagrelor In CABG PatieNts Trial), aims to compare the effects of using ticagrelor in addition to aspirin versus aspirin alone for one month following CABG surgery. The study focuses on the incidence of ischemic events and graft failure within one year after the surgery.

Table of Contents

What is Acetylsalicylic Acid?

Acetylsalicylic acid, commonly known as Aspirin, is a medication used to treat various conditions, including heart-related issues. In this context, we’re discussing a specific form of the drug called “ACETYLSALICYLIC ACID PH. EUR.” or Aspirin protect 100 mg[1]. This medication comes as a gastro-resistant tablet, which means it’s designed to pass through your stomach and be absorbed in your intestines, potentially reducing stomach irritation.

Medical Condition Treated

The primary medical condition treated with this medication in the context of the study is coronary artery disease[1]. This is a heart condition where the main blood vessels that supply your heart (coronary arteries) become damaged or diseased, usually due to the buildup of fatty deposits called plaque.

Use in CABG Patients

The study focuses on patients undergoing a procedure called Coronary Artery Bypass Graft (CABG) surgery[1]. This is a type of heart surgery used to improve blood flow to the heart in people with severe coronary artery disease. The study aims to compare the effects of using acetylsalicylic acid alone versus using it in combination with another drug called ticagrelor for one month after the surgery.

Dosage and Administration

According to the study information, the maximum daily dose of acetylsalicylic acid is 150 mg, taken orally (by mouth)[1]. The maximum total dose amount over the treatment period is 4500 mg, with the treatment lasting up to 30 days. However, always follow your doctor’s instructions regarding dosage, as it may vary based on your specific condition.

Potential Benefits

The study aims to determine if this medication can help reduce the occurrence of certain events after CABG surgery. These potential benefits include[1]:

  • Reducing the risk of death
  • Lowering the chance of stroke
  • Decreasing the likelihood of heart attacks (myocardial infarction)
  • Reducing the need for repeat revascularization (additional procedures to restore blood flow)
  • Improving the success rate of the bypass grafts

Who Can Take This Medication?

Based on the study’s inclusion criteria, this medication may be suitable for[1]:

  • Patients undergoing elective first-time CABG surgery with at least one saphenous vein graft (a type of blood vessel used in the bypass)
  • Individuals with chronic coronary disease
  • Patients who can comply with study procedures and follow-up for at least 5 years

Who Should Not Take This Medication?

The study lists several conditions that would exclude a patient from using this medication. These include[1]:

  • Recent (within 1 year) acute coronary syndrome or heart attack
  • Recent stent placement (PCI) requiring continued dual antiplatelet therapy
  • Women who can become pregnant
  • Major complications during or after surgery, such as stroke, heart attack, or severe bleeding
  • Current or planned use of blood thinners (oral anticoagulation)
  • Atrial fibrillation (a type of irregular heartbeat)
  • Severe kidney, liver, or respiratory problems
  • Cancer or other conditions with a life expectancy less than 5 years
  • Known allergies or contraindications to aspirin

It’s crucial to discuss your medical history and any current medications with your doctor before starting this or any new treatment.

Aspect Details
Trial Name The One-Month DAPT with Ticagrelor In CABG PatieNts Trial (ODIN)
Trial Category Phase 3b
Medical Condition Coronary Artery Disease
Main Objective Compare ticagrelor plus ASA vs ASA alone for 1 month on 1-year ischemic events and graft failure in CABG patients
Key Inclusion Criteria Elective first-time CABG, ≥1 saphenous vein graft, chronic coronary disease
Key Exclusion Criteria Recent ACS, need for dual antiplatelet therapy, inability to undergo CCTA, contraindications to aspirin or ticagrelor
Primary Endpoint Composite of death, stroke, MI, repeat revascularization, and graft failure at 1 year
Acetylsalicylic Acid Ph. Eur. Details Max daily dose: 150 mg, Treatment period: 30 days, Route: Oral use
Data Sharing Pseudonymized participant data will be shared with the sponsor’s data coordinating center

FAQ

  • What is the main goal of the ODIN clinical trial? The main goal of the ODIN trial is to compare the effect of ticagrelor plus aspirin versus aspirin alone for one month on the one-year incidence of ischemic events and graft failure in patients undergoing CABG surgery for stable ischemic heart disease.
  • Who can participate in this clinical trial? Participants must have chronic coronary disease and be scheduled for elective first-time CABG surgery with at least one saphenous vein graft. They must be able to provide informed consent and comply with study procedures, including follow-up for at least 5 years.
  • What are some reasons why someone might not be eligible for this trial? Exclusion criteria include recent acute coronary syndrome, need for dual antiplatelet therapy, inability to undergo coronary CT angiography, pregnancy potential, major perioperative complications, use of oral anticoagulation, atrial fibrillation, and contraindications to aspirin or ticagrelor.
  • What outcomes will the researchers be measuring? The primary outcome is a composite of death, stroke, myocardial infarction, repeat revascularization, and graft failure at one year. Secondary outcomes include similar composites with the addition of major bleeding events and quality of life measures over a 5-year period.
  • How is Acetylsalicylic Acid Ph. Eur. (aspirin) used in this trial? Acetylsalicylic Acid Ph. Eur. is used as a comparator in this trial. One group of patients will receive aspirin alone, while the other group will receive aspirin plus ticagrelor. The maximum daily dose of aspirin used is 150 mg, with a total treatment period of 30 days.

Ongoing Clinical Trials on Acetylsalicylic Acid Ph. Eur.

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Sweden

Glossary

  • CABG: Coronary Artery Bypass Graft, a surgical procedure that improves blood flow to the heart by using blood vessels from other parts of the body to bypass blocked coronary arteries.
  • Ischemic events: Occurrences where blood flow to a part of the body is reduced, potentially causing damage to tissues. In the context of heart disease, this often refers to events like heart attacks or strokes.
  • Graft failure: A situation where the blood vessel used in the CABG surgery becomes blocked or narrowed, reducing its effectiveness in improving blood flow to the heart.
  • Dual Antiplatelet Therapy (DAPT): A treatment approach using two antiplatelet medications together, typically aspirin and another drug like ticagrelor, to reduce the risk of blood clots.
  • Ticagrelor: An antiplatelet medication that helps prevent blood clots by making platelets less sticky.
  • Acetylsalicylic Acid Ph. Eur.: The pharmaceutical-grade form of aspirin, an antiplatelet medication that helps prevent blood clots and reduce inflammation.
  • Coronary Artery Disease: A condition where the major blood vessels that supply the heart become damaged or diseased, often due to plaque buildup.
  • Revascularization: A procedure to restore blood flow to a part of the body, such as the heart, often through surgery or less invasive techniques.
  • Myocardial Infarction: The medical term for a heart attack, where blood flow to part of the heart muscle is blocked, causing damage.
  • Gastro-resistant tablet: A type of pill designed to resist breakdown in the stomach, allowing the medication to be released in the intestines instead.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-ticagrelor-and-acetylsalicylic-acid-in-patients-with-coronary-artery-disease-undergoing-cabg-surgery/