Short Dual Antiplatelet Therapy with Ticagrelor, Aspirin and Clopidogrel vs Standard Therapy in Chronic Coronary Syndrome Patients Undergoing PCI

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What is this study about?

Patients with Chronic Coronary Syndrome who undergo percutaneous coronary intervention (PCI) have arteries opened to improve blood flow to the heart. After this procedure, doctors usually prescribe two medicines that keep blood cells called platelets from sticking together, a strategy known as dual antiplatelet therapy. One of the medicines commonly used is acetylsalicylic acid, often called aspirin, and another is a drug called ticagrelor or clopidogrel, which work in different ways to reduce clot risk.

The study aims to see whether a short course of the two‑medicine DAPT for one month, followed by only ticagrelor alone, can lower the chance of net adverse clinical events compared with the standard six‑month two‑medicine plan that includes clopidogrel. Participants will be assigned to one of the two treatment paths, take the assigned pills as directed, and have a series of routine visits over the next six months to check their health and any bleeding, which will be graded using the BARC system.

During the visits, simple checks such as blood pressure, heart rhythm, and brief questionnaires will be done, and any problems will be recorded. The study follows each person for at least six months to collect information on heart‑related events, bleeding, and overall well‑being.

1 first visit and enrollment

you will meet the study doctor who will confirm that you meet the study criteria and will ask you to sign the consent form.

the doctor will explain the two possible treatment plans and will assign you to one of them.

2 receive study medication and instructions

you will be given the tablets that belong to your assigned group.

aspirin tablets contain 100 mg of acetylsalicylic acid and are taken by mouth.

if you are in the short‑duration group, you will also receive ticagrelor tablets that contain 60 mg of the active substance; if you are in the standard‑duration group, you will receive clopidogrel tablets that contain 75 mg.

the study staff will show you how to take the tablets, how many to take each day, and how long to continue each medicine.

3 start dual antiplatelet therapy (both medicines together)

for the first month you will take aspirin 100 mg together with either ticagrelor 60 mg (short‑duration group) or clopidogrel 75 mg (standard‑duration group).

both tablets are taken by mouth as directed, usually once each day, unless the doctor tells you otherwise.

4 continue medication according to assigned schedule

if you are in the short‑duration group, after completing one month you will stop taking aspirin and will keep taking only ticagrelor 60 mg each day for the rest of the study period.

if you are in the standard‑duration group, you will continue taking both aspirin 100 mg and clopidogrel 75 mg each day for a total of six months.

5 follow‑up visits

you will attend a visit at the end of the first month to check that the medicines are being taken correctly and to assess any side effects.

additional visits will be scheduled at six months and at twelve months to evaluate your health status and to record any events that are part of the study outcomes.

6 final assessment and study completion

at the twelve‑month visit the study doctor will perform a final assessment, collect information about any heart‑related problems, bleeding events, or other health changes, and will end your participation in the trial.

after this visit you will no longer be required to take the study tablets unless your regular doctor decides otherwise.

Who Can Join the Study?

Be 18 years of age or older.
Have an acceptable risk of bleeding; even patients who meet the ARC‑HBR criteria (a definition for high bleeding risk) can join if the doctor believes a 6‑month antiplatelet plan is safe.
Have no medical reason that would stop the use of the study medicines: aspirin, clopidogrel, or ticagrelor.
Have been diagnosed with chronic coronary syndrome (CCS) according to current heart‑disease guidelines.
Have had a successful percutaneous coronary intervention (PCI) with placement of one or more new‑generation drug‑eluting stents (DES) or treatment with a drug‑coated balloon (DCB).
Require dual antiplatelet therapy (DAPT) after the PCI procedure (meaning two blood‑thinning medicines together).
Be willing and able to follow all study visits, procedures, and follow‑up assessments.
Sign an informed consent form after the PCI, confirming understanding and agreement to take part.
Show kidney function of at least creatinine clearance ≥30 mL/min, measured using the Cockcroft‑Gault formula (a calculation that estimates how well the kidneys filter waste).
Be expected by the doctor to live longer than one year.
Be hemodynamically stable at the time of randomization (meaning stable blood pressure and heart function).

Who Cannot Join the Study?

Acute coronary syndrome (ACS) (a sudden heart problem) including STEMI (a severe heart attack with full artery blockage), NSTEMI (a heart attack without full blockage), or unstable angina (new or worsening chest pain) that occurred within the last 6 months.
Life expectancy less than 1 year because of other serious illnesses such as cancer or advanced kidney failure.
Being enrolled in another clinical trial that could affect the results of this study.
Severe anemia (low red blood cell count) with hemoglobin less than 9 g/dL that has not been fixed before the study starts.
Unable or unwilling to give informed consent (agree to take part after understanding the study) or to follow the study’s follow‑up schedule.
Having had a stroke that left lasting problems, or a disabling stroke (measured as mRS ≥3, which means moderate to severe disability).
Planning another heart‑opening procedure (PCI) or other blood‑vessel reopening (revascularization) within 6 months after the first procedure.
Needing long‑term blood‑thinning medication (oral anticoagulation) for conditions such as atrial fibrillation (irregular heartbeat), mechanical heart valves, or blood clots in the veins (venous thromboembolism).
Having a major bleeding event (classified as BARC Types 3b or 5) like serious stomach or brain bleeding in the past 6 months.
Severe liver disease (hepatic impairment) or active liver problems, or liver enzymes (transaminases) more than three times the normal upper limit.
Known platelet disorder, clotting disorder (coagulopathy), or low platelet count (thrombocytopenia under 100,000 per mm³).
Allergy or other reason not to use aspirin, clopidogrel, or ticagrelor, or a drug interaction that makes these medicines unsafe.
Current active bleeding or a high risk of bleeding that the doctor believes makes dual antiplatelet therapy (DAPT) unsafe.
Pregnancy, breastfeeding, or being able to become pregnant without using effective birth control.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.07.2026

Trial locations

Investigated Drugs:

Ticagrelor is a medication that helps prevent blood clots by making platelets less likely to stick together. In this study, patients took ticagrelor together with aspirin for one month (called dual antiplatelet therapy) and then continued taking only ticagrelor for the rest of the study period. The goal was to see if this short combination followed by ticagrelor alone could lower the chance of serious heart problems compared with the standard treatment.

Aspirin (acetylsalicylic acid) is a common drug that also reduces the ability of platelets to form clots. In the trial, aspirin was given with ticagrelor for the first month as part of the short dual antiplatelet therapy, and it was also used together with clopidogrel in the standard treatment group for six months. Its role was to help prevent clot‑related events during the early period after the heart procedure.

Clopidogrel is another antiplatelet medication that works differently from aspirin but also stops platelets from clumping together. In the study, clopidogrel was taken with aspirin for six months as the standard dual antiplatelet therapy. The researchers used it as a comparison to see if the ticagrelor‑based approach was more effective at reducing heart‑related problems.

Investigated Diseases:

Chronic coronary syndrome

Chronic coronary syndrome – Chronic coronary syndrome is a long‑term condition where the arteries that supply blood to the heart become narrowed or blocked. It develops slowly as fatty deposits build up inside the vessel walls. Over time the narrowing reduces the amount of oxygen‑rich blood that reaches the heart, especially during physical activity, causing chest discomfort or shortness of breath. Repeated episodes of reduced blood flow create a pattern of stable symptoms. The condition can remain relatively unchanged for years, but the narrowing may gradually increase, making symptoms occur more often.

Trial ID:

2026-526368-18-00

NCT ID:

NCT07080684

Trial Phase:

Therapeutic confirmatory (Phase III)

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Short Dual Antiplatelet Therapy with Ticagrelor, Aspirin and Clopidogrel vs Standard Therapy in Chronic Coronary Syndrome Patients Undergoing PCI

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?