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Could one blood thinner be safer than two for older heart patients?

NCT ID NCT06535568

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether taking just one blood thinner (single antiplatelet therapy) is safer and as effective as taking two (dual antiplatelet therapy) in older adults or those at high risk of bleeding who have had a balloon procedure to open blocked heart arteries. About 576 participants will be randomly assigned to one of the two treatment groups and followed for 12 months to track bleeding and heart-related events. The goal is to find the best balance between preventing clots and avoiding bleeding complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 576 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Male and female patients who meet the following criteria: * Age ≥ 75 years or age ≥ 18 years at high bleeding risk; * Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels; * Stable or unstable coronary syndromes; * De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation); * Informed consent to participate in the study given by the patient or impartial witness. Exclusion Criteria: * Stent implantation during index or recent (\<6 months) procedure; * Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated; * Pregnancy at the time of hospitalization; * Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer; * ST-elevation myocardial infarction; * Life expectancy \<12 months; * Left ventricular ejection fraction \<30%; * Visible thrombus at lesion site; * Target lesion/vessel with any of the following characteristics: * severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory); * left main stem stenosis \>50%; * target lesion is in the left main stem; * chronic total occlusion with anticipated necessity of retrograde approach; * lesion is in a bypass graft. * History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs); * History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage; * Acute gastrointestinal ulcers; * Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding); * Severe renal impairment (eGFR \< 30 mL/min); * Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST \> 2 x ULN or total bilirubin \>1.5 x ULN); * Severe cardiac failure (NYHA grade III or IV); * Combination with methotrexate at doses of 15 mg/week or more; * Patients with baseline neutrophil counts \< 1500 cells/mm³; * Breastfeeding women; * Full-blown thyrotoxicosis; * Patients with a very high risk of thrombosis.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Auxologico Milano

    RECRUITING

    Milan, MI, 20149, Italy

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