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Study Comparing Single and Dual Antiplatelet Therapy with Clopidogrel and Acetylsalicylic Acid in Elderly Patients or Those at Risk of Bleeding After Balloon Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is about comparing two types of antiplatelet therapy in people who have undergone a percutaneous coronary intervention (a minimally invasive procedure to treat narrowed or blocked coronary arteries) using drug-coated balloons. The study focuses on elderly patients (75 years or older) or those at high bleeding risk. Patients in the study have stable or unstable coronary syndromes (conditions involving reduced blood flow to the heart) and have successfully undergone balloon surgery to open narrowed heart vessels.

The research compares single antiplatelet therapy (SAPT) with dual antiplatelet therapy (DAPT). Antiplatelet medications help prevent blood clots from forming. The purpose is to determine if using just one antiplatelet medication is as effective as using two in preventing complications after the procedure, while potentially reducing bleeding risks.

The study will follow patients for 12 months after their procedure to track outcomes such as death from any cause, the need for additional procedures on the treated blood vessel, and heart attacks related to the treated vessel. Quality of life and functional status will be assessed using questionnaires at different timepoints throughout the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Beginning

    You have just undergone a successful balloon angioplasty procedure called Drug-Coated Balloon (DCB) angioplasty on one, two, or three of your coronary vessels.

    After your procedure, you will be randomly assigned to one of two medication groups for your follow-up care.

  2. Step 2

    Medication Assignment

    You will be placed in either the single antiplatelet therapy (SAPT) group or the dual antiplatelet therapy (DAPT) group.

    The SAPT group will receive one blood-thinning medication (either clopidogrel or acetylsalicylic acid).

    The DAPT group will receive two blood-thinning medications (both clopidogrel and acetylsalicylic acid, also known as aspirin).

  3. Step 3

    Treatment Period

    You will take your assigned medication(s) as directed by your healthcare provider for the duration of the study.

    The study will last for 12 months after your balloon angioplasty procedure.

  4. Step 4

    Follow-up Visits

    You will have several follow-up appointments over the 12-month period.

    At these visits, your doctors will check for any heart-related events or complications.

    Specifically, they will monitor for signs of major adverse cardiac events (MACE), which include death from any cause, the need for additional procedures in the treated blood vessel, or spontaneous heart attacks related to the treated vessel.

  5. Step 5

    Quality of Life Assessments

    You will complete a quality of life questionnaire called EQ-5D-5L at four different times: at the beginning of the study, after 1 month, after 6 months, and at the end of the study (12 months).

    This questionnaire helps evaluate how your heart condition and the treatment affect your daily life and overall well-being.

  6. Step 6

    Monitoring for Bleeding

    Throughout the study period, your healthcare providers will monitor you for any bleeding events.

    They will specifically look for BARC 2, 3, or 5 bleedings, which is a standardized way to classify the severity of bleeding complications.

  7. Step 7

    Study Completion

    The study will conclude after 12 months of follow-up.

    At this point, your healthcare provider will discuss the results of your treatment and any next steps for your ongoing care.

Who can join the trial?

7 criteria

  • You must be at least 75 years old or have a high risk of bleeding
  • You must have had a successful procedure called PCI with Essential Pro DCB (a special balloon used to open blocked heart arteries without leaving a stent)
  • Your procedure must have been done on 1, 2, or 3 heart arteries
  • Your treated heart arteries must be between 2.0 and 4.0 mm in diameter
  • You must have either stable or unstable coronary syndromes (conditions where the blood flow to the heart muscle is reduced or blocked)
  • You must have had treatment for de novo coronary lesions (new blockages in your heart arteries that haven't been treated before)
  • You must provide informed consent to participate in the study (either yourself or through an impartial witness)

Who cannot join the trial?

6 criteria

  • You cannot participate if you do not have stable or unstable coronary syndromes (conditions where the blood flow to the heart is reduced or blocked) that have been treated with successful PCI (a procedure to open blocked arteries in the heart).
  • You cannot participate if you have not undergone DCB angioplasty (a procedure that uses a special balloon coated with medication to open narrowed arteries).
  • You cannot participate if your DCB angioplasty procedure was not successful.
  • You cannot participate if you are unable to complete the required 12-month follow-up period.
  • You cannot participate if you are unable or unwilling to take either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT) as required by the study.
  • You cannot participate if you have any condition that would make it unsafe for you to be in the study, as determined by the study doctor.
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Investigated drugs

  • Single Antiplatelet Therapy (SAPT)

    This therapy involves taking a single medication to reduce blood clotting. It helps prevent blood clots that can cause heart attacks and strokes. In this study, it's being used after a procedure called drug-coated balloon angioplasty, which opens narrowed blood vessels in the heart.

  • Dual Antiplatelet Therapy (DAPT)

    This therapy involves taking two different medications together to reduce blood clotting. The combination provides stronger protection against blood clots compared to single therapy. Like SAPT, it's used after drug-coated balloon angioplasty to help keep treated blood vessels open.

  • Drug-Coated Balloon (DCB)

    This is a medical device used during angioplasty procedures to open narrowed or blocked blood vessels in the heart. The balloon is coated with medication that helps prevent the blood vessel from narrowing again after the procedure.

What is already known about the treatment

Antiplatelet therapy – A medical approach used in patients who have undergone percutaneous coronary intervention (PCI), such as angioplasty with drug-coated balloons (DCB). It comes in two forms: single antiplatelet therapy (SAPT) which involves one medication, or dual antiplatelet therapy (DAPT) which combines two medications to prevent blood clots. These medications are typically taken orally as tablets. Currently, there is ongoing research to determine if SAPT is as effective as DAPT in elderly or high bleeding risk patients who have received DCB treatment. Antiplatelet medications work by preventing platelets in the blood from sticking together to form clots, which can block blood vessels and lead to heart attacks. This therapy is primarily indicated for patients with coronary artery disease who have undergone procedures to open blocked arteries.

Investigated diseases

  • Stable Coronary Syndrome

    It refers to a pattern of predictable chest pain (angina) that occurs with physical exertion or emotional stress and is relieved by rest or nitroglycerin. This condition is characterized by the narrowing of coronary arteries due to atherosclerotic plaque buildup, which restricts blood flow to the heart muscle. The symptoms typically follow a consistent pattern and don't change in frequency or severity over time. The reduced blood flow causes temporary oxygen deprivation to heart muscle cells during increased demand but doesn't lead to permanent damage. Over time, atherosclerosis may progressively worsen, causing increasingly limited exercise tolerance.

  • Unstable Coronary Syndrome

    This condition represents a more acute phase of coronary artery disease, characterized by sudden worsening of angina symptoms, including chest pain that occurs at rest or with minimal exertion. It results from partial rupture of atherosclerotic plaques, leading to blood clot formation that partially blocks coronary arteries. The symptoms are unpredictable and may include new-onset severe angina, worsening of previously stable angina, or prolonged angina at rest. This condition represents an intermediate state between stable angina and myocardial infarction. Without intervention, unstable coronary syndrome can progress to complete blockage of a coronary artery.

  • Myocardial Infarction

    It occurs when blood flow to a part of the heart muscle is blocked, causing oxygen deprivation and damage to heart tissue. The blockage typically results from a complete rupture of an atherosclerotic plaque with subsequent blood clot formation in a coronary artery. As heart cells are deprived of oxygen, they begin to die within minutes, causing permanent heart muscle damage. The extent of damage depends on the size of the affected area, duration of blood flow obstruction, and whether collateral blood vessels provide alternative circulation. Myocardial infarction can be categorized as Q-wave or non-Q-wave based on electrocardiogram findings.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519706-13-00Protocol codePICCOLETO IV-EPIC 38Estimated enrolment576 patientsSponsorFondazione Ricerca e Innovazione Cardiovascolare

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