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:

• People who are at least 19 years old.
• People who are able to understand the risks, benefits, and alternatives involved, and are willing to sign a consent form.
• People who have a stable, long-term heart condition (chronic coronary syndrome) and had a specific type of heart procedure called drug-coated balloon (DCB) angioplasty on at least one new blockage in a blood vessel of a certain minimum size.
• People who are considered at high risk of bleeding, based on at least one of the following: being 75 or older; having low haemoglobin or anaemia requiring a blood transfusion in the past 4 weeks; any previous bleeding in the brain; being admitted to hospital for bleeding in the past 12 months; having been diagnosed or treated for a non-skin cancer within the past 3 years; a plan to take certain anti-inflammatory medicines (NSAIDs, not aspirin) or steroids daily for more than 30 days after the procedure; planned surgery within the next 12 months that would require stopping certain blood-thinning medicines; significant kidney problems or being on dialysis; certain blood disorders affecting platelets or clotting; severe chronic liver disease with specific serious complications; or an expected inability to take prescribed heart medicines after the procedure for other medical reasons.
• People who completed a standard course of dual antiplatelet therapy (two blood-thinning medicines taken together) for 1 to 3 months after their procedure, followed by a single blood-thinning medicine (either aspirin or a P2Y12 inhibitor) for at least 1 year after that procedure.
• People who have had no significant bleeding events and no serious heart-related events (such as heart-related death, heart attack, or needing a repeat procedure) for at least 1 year since their original procedure.

Who may not be able to join:

• People who are unable to give consent.
• People who have had a recent heart attack or unstable chest pain (unstable angina).
• People who have a known allergy or intolerance to aspirin, P2Y12 inhibitor medicines, or any component of the drug-coated balloon used in the procedure.
• People who need to take blood-thinning medicines taken by mouth (oral anticoagulants).
• People who also had a drug-eluting stent placed during their original procedure.
• People who have previously had a stroke caused by a blood clot, or a previous heart attack.
• People who have a condition affecting the blood vessels in their legs or other limbs (peripheral arterial occlusive disease).
• People with certain specific findings on their heart artery imaging, including: disease in the main left heart artery; a blockage caused by scar tissue inside a previous stent; a blockage located in a bypass graft; a complex branching blockage that requires a specific two-stent approach; or significant remaining blockages in other heart arteries after the procedure (confirm with trial site for precise definitions).
• People who have a serious non-heart-related illness with a life expectancy of less than 1 year.
• People who, in the judgement of the site investigator, are unlikely to follow the study requirements.
• People who have experienced cardiogenic shock (the heart cannot pump enough blood) or cardiac arrest.
• People with severely reduced heart pumping function (ejection fraction below 30%).
• People with severe heart valve disease that requires open heart surgery.
• Women who are pregnant or breastfeeding.

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