BridgeMD
New treatment option for Coronary Disease
Official title Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
ClinicalTrials.gov ID: NCT06535568
What this study is testing
What is Single antiplatelet therapy (SAPT)?
Single antiplatelet therapy (SAPT) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for coronary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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);
You likely can't join if
- 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...
- 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...
- ST-elevation myocardial infarction;
- Life expectancy \<12 months;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, MI, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, MI, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.