Could one blood thinner be safer than two for older heart patients?
NCT ID NCT06535568
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 576 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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IRCCS Auxologico Milano
RECRUITINGMilan, MI, 20149, Italy
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