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Study comparing single versus dual antiplatelet therapy in elderly patients or patients at risk of bleeding undergoing balloon surgery.
EU CTIS ID: 2024-519706-13-00
What this study is testing
The primary objective of the study is to verify the superiority of SAPT vs. DAPT in terms of Net Adverse Clinical Events (NACE), defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3 or 5) at 12 months. We thus suppose that SAPT may provide similar benefits to DAPT regarding rate of MACE, and may offer improved net clinical benefit in terms of NACE due to reduced bleeding risk.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels
- De novo coronary lesions in vessels with diameter >=2.0 and <=4.0 mm (visual estimation)
- Stable or unstable coronary syndromes
- Informed consent to participate in the study given by the patient or impartial witness
- Male and female patients age ≥ 75 years or at high bleeding risk
You likely can't join if
- Stent implantation during index or recent (<6 months) procedure
- 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)
See the full eligibility criteria
- Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels
- De novo coronary lesions in vessels with diameter >=2.0 and <=4.0 mm (visual estimation)
- Stable or unstable coronary syndromes
- Informed consent to participate in the study given by the patient or impartial witness
- Male and female patients age ≥ 75 years or at high bleeding risk
- Stent implantation during index or recent (<6 months) procedure
- 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
- 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
- Full-blown thyrotoxicosis
- Patients with a very high risk of thrombosis
- 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.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.