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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Presidio Ospedaliero S. Antonio Abate	Erice TP	Italy
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale Mater Salutis Di Legnago	Legnago	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Leon	Leon	Spain
Azienda USL Toscana Sud Est	Arezzo	Italy
Azienda Ospedaliero – Universitaria di Parma	Parma	Italy
Hqipgwog Ujqqnrbhpnvwn Dd Ln Pimxfncj	Madrid	Spain
Hpnuzgia Upcoqcaiurzlg Mqndjoi Da Vpfrhtgvnd	Santander	Spain
Icarh &clrwsw Icngqhhw Nigctghn da Cpzdbxtei Cyhvaelov ea di Copwdgwukgo Iskxtfticvbluaiei	Luxembourg	Luxembourg
Alihyag Owuuqybfmip Ownwyfqn Rcguvbu Vioaq Szuor Cofvemyt	Palermo	Italy
Ahdctvq Omaiibhljixaimdajrouphjxl Dc Ceuvrcb	Cosenza	Italy
Cep db Cjkkrqxir Hqhzkup Cmtdq Mnmhu Ccwzc	Charleroi	Belgium
Hlzukqfg Dh Lf Slvey Cqbb I Sgwr Pue	Barcelona	Spain
Isvcno	Bonheiden	Belgium
Cqxxjnxs Hebjkrwkcmqt Uukoridbcujzz Dl Veey	Vigo	Spain
Hfcrgpeh Vhdb dmrxktsj	Barcelona	Spain
Imsdl Otlhqrlh Abaumunohu Sft Lhad	Milan	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.11.2025
Italy	Recruiting	15.11.2025
Luxembourg	Not yet recruiting	15.11.2025
Spain	Recruiting	15.11.2025

Trial locations

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.

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 ID:

2024-519706-13-00

Protocol code:

PICCOLETO IV-EPIC 38

NCT ID:

NCT06535568

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?