Single versus dual antiplatelet therapy after drug-coated balloon angioplasty in elderly or high-bleeding-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PICCOLETO IV-EPIC 38 is an international, multicenter, open-label randomized trial that compares single antiplatelet therapy (SAPT) with routine dual antiplatelet therapy (DAPT) after successful percutaneous coronary intervention using the Essential Pro drug-coated balloon in native coronary arteries 2.0–4.0 mm in diameter. Eligible patients are aged 75 years or older or adults classified as high bleeding risk and may have stable or unstable coronary syndromes. Participants are randomized after successful DCB angioplasty and followed for rates of ischemic events and bleeding complications. The trial aims to determine whether SAPT can provide comparable ischemic protection with a lower bleeding burden compared with DAPT in this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Auxologico Milano
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Bernardo Cortese, MD MSc
• Email: bcortese@gmail.com
• Phone: 216-296-9747

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Freesolve resorbable magnesium scaffold vs. Xience stent for up to two new heart artery lesions

  This trial tests whether the Freesolve resorbable magnesium scaffold works as well as the Xience drug-eluting stent for treating up to two new coronary artery lesions in adults.

  Recruiting at 3 sites Teleflex · Washington D.C., District of Columbia and 2 other locations · NCT07258290

• Coronary CT angiography–guided calcium modification during PCI for calcified coronary artery disease

  This study will see if using CT angiography to plan calcium treatment before stenting helps people with flow-limiting, calcified coronary artery disease have better stent results and faster procedures compared with the usual ultrasound-guided PCI while keeping similar safety.

  Recruiting at 10 sites Fundación EPIC · Boston, Massachusetts and 14 other locations · NCT07286578

• Comparing heart imaging techniques for coronary artery disease

  This study is testing if a new heart imaging method can better identify problems in patients suspected of having coronary artery disease compared to a traditional imaging technique.

  Recruiting Semmelweis University · Budapest, Budapest · NCT06670768

• Evaluating the effectiveness and safety of Synergy XD and Megatron stents

  This study is testing how well and safely the Synergy XD and Megatron stents work for people with coronary artery disease compared to other stents in real-life situations.

  Recruiting at 19 sites Asan Medical Center · Anyang and 22 other locations · NCT05044273

• Short-term high-dose rosuvastatin effects on coronary plaque using photon-counting CT

  This trial tests whether a short course of intensified rosuvastatin (40 mg) changes coronary plaque composition and flow on photon‑counting coronary CT in statin‑naive adults with stable chest pain and mild atherosclerosis.

  Recruiting Semmelweis University · Budapest, Budapest · NCT06603363

• Using a smartphone device to record 12-lead ECGs for heart attack diagnosis

  This study is testing a smartphone device that records heart activity to see if it can help doctors quickly diagnose heart attacks in adults who come to the emergency room with chest pain.

  Recruiting at 2 sites AliveCor · Rochester, Minnesota and 3 other locations · NCT06271577

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.