Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older

• Men, or women who are not pregnant

• People who have had an acute coronary syndrome (a sudden, serious heart condition such as a heart attack) and need a procedure called PCI, which opens blocked heart arteries using a small balloon and often a stent

• People for whom heart bypass surgery (a different type of heart operation) is not ruled out

• People considered to be at high risk of bleeding, based on a specific medical scoring system — this means meeting at least one "major" or two "minor" risk factors from the lists below:

  Major bleeding risk factors include:

  • Needing long-term blood thinning tablets
  • Severely reduced kidney function
  • Moderate to severe low red blood cell levels (anaemia)
  • A serious bleeding episode requiring a hospital stay or blood transfusion within the past 6 months, or repeated bleeding episodes
  • A long-term condition that causes abnormal bleeding
  • A very low platelet count (platelets help blood clot) before the procedure
  • Liver cirrhosis with high pressure in the liver's blood vessels
  • A diagnosis or treatment for cancer (other than certain skin cancers) in the past 12 months
  • A history of bleeding inside the brain that happened on its own
  • Bleeding inside the brain caused by injury within the past 12 months
  • A known abnormal tangle of blood vessels in the brain
  • A moderate to severe stroke caused by reduced blood flow within the past 6 months
  • Major surgery or serious physical trauma within the 30 days before the procedure
  • Major surgery that cannot be postponed, planned during the period when dual blood-thinning medication would be needed

  Minor bleeding risk factors include:

  • Age 75 or older
  • Mildly to moderately reduced kidney function
  • Mild anaemia (low red blood cell levels)
  • A serious bleeding episode requiring hospital care between 6 and 12 months before the procedure
  • Ongoing use of anti-inflammatory pain medicines (such as ibuprofen) or steroids after the procedure
  • A stroke caused by reduced blood flow that occurred more than 6 months before the procedure

• People who are able to understand the goals of the trial and agree to participate by signing a consent form

Based on the heart artery images (angiographic criteria), people may also need to meet these conditions:

• The main artery being treated must be a natural coronary artery (not a previously placed bypass graft)
• The blockage in that artery must be significant enough to warrant treatment, either blocking 70% or more of the artery, or 50–70% with additional evidence of reduced blood flow to the heart
• There must be at least one other artery with a blockage that also needs treatment
• That additional blockage must be suitable for a planned, non-urgent procedure within one month

Who may not be able to join:

• People showing signs of heart failure, including those with significantly reduced heart pumping function, or moderate-to-severe heart failure symptoms (confirm with trial site for specific classifications)
• People in cardiogenic shock (when the heart is suddenly unable to pump enough blood to meet the body's needs)
• People with known allergies or medical reasons to avoid aspirin, clopidogrel, ticagrelor, heparin, contrast dyes used during heart procedures, or materials used in drug-coated stents
• People whose life expectancy is less than 12 months, or who may have difficulty attending follow-up appointments
• People currently enrolled in another clinical drug or medical device trial that has not yet reached its main measurement point
• People with a history of substance misuse, such as alcohol, cocaine, or heroin
• People with serious heart rhythm problems (confirm with trial site for specific types)
• People with other medical conditions that the trial doctors consider make participation unsuitable

Based on heart artery images, people may also not be eligible if:

• The blockage is in the left main coronary artery (the main artery supplying the left side of the heart)
• The blockage is in a previously placed bypass graft
• There is a large blood clot visible in the artery being treated

Important: Always verify eligibility with the trial site directly before applying.