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Safety and efficacy of very short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy in older patients undergoing percutaneous coronary intervention
EU CTIS ID: 2023-507545-28-00
What this study is testing
To determine whether short DAPT (dual antiplatelet therapy) followed by SAPT (single antiplatelet therapy) with P2Y12 inhibitor is non-inferior to standard DAPT regarding net clinical benefit (a composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5) at 1 year in elderly patients undergoing PCI
- 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
- - Patients ≥ 65 years
- - Successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent (final TIMI 3 flow and visually estimated residual diameter stenosis <30%) for acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina) or chronic coronary syndrome (elective PCI). Inclusion is possible after the last PCI procedure in staged procedure.
- - Randomization must be performed before the discharge from the study site.
- - Written informed consent
- - Social security affiliated
You likely can't join if
- - PCI without drug-eluting stent implantation or with a bioresorbable scaffold
- - Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
- - Use of fibrinolytic therapy within 24 hours of PCI
- - Severe renal insufficiency (MDRD creatinine clearance < 30 ml/min/m2) and/or dialysis
- - Increased bleeding risk (prior hemorrhagic stroke; stroke < 30 days; brain injury<6 months; history of intracranial tumor or intracranial hemorrhage; internal bleeding<6 weeks; active bleeding; anemia (hemoglobin ≤ 8 g/dl) or thrombocytopenia (platelets < 100 000 G/L); major surgery<3 weeks)
- patients with poor quality of the downstream territory with diffuse distal coronary disease
See the full eligibility criteria
- - Patients ≥ 65 years
- - Successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent (final TIMI 3 flow and visually estimated residual diameter stenosis <30%) for acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina) or chronic coronary syndrome (elective PCI). Inclusion is possible after the last PCI procedure in staged procedure.
- - Randomization must be performed before the discharge from the study site.
- - Written informed consent
- - Social security affiliated
- - PCI without drug-eluting stent implantation or with a bioresorbable scaffold
- - Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
- - Use of fibrinolytic therapy within 24 hours of PCI
- - Severe renal insufficiency (MDRD creatinine clearance < 30 ml/min/m2) and/or dialysis
- - Increased bleeding risk (prior hemorrhagic stroke; stroke < 30 days; brain injury<6 months; history of intracranial tumor or intracranial hemorrhage; internal bleeding<6 weeks; active bleeding; anemia (hemoglobin ≤ 8 g/dl) or thrombocytopenia (platelets < 100 000 G/L); major surgery<3 weeks)
- patients with poor quality of the downstream territory with diffuse distal coronary disease
- women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy
- - increased thrombotic risk related to the patient (previous stent thrombosis, ≥ 2 previous myocardial infarction, symptomatic peripheral artery disease, chronic systemic inflammatory disease treated with corticoids or immunosuppressive drug) or the procedure (left main treated, ≥3 stents/treated lesions, total length of stents>60mm, bifurcation lesion with stents in each branch, stenting of the last patent vessel)
- - Life expectancy less than 1 year
- - Participation in another interventional trial
- - Patients considered as vulnerable by the investigators because of medical, psychological or social conditions: ▪ Patients with known or discovered severe cognitive impairment ▪ Patients with treated or untreated severe psychological or psychiatric conditions ▪ Patients with uncorrected severe hearing or visual handicap ▪ Patients with addictive alcohol, drug or substance abuse ▪ Patients with protective measures (guardianship, tutorship, curatorship) ▪ Any other condition considered by the investigators as not warranting informed consent
- - Planned coronary artery bypass grafting or cardiac surgery
- - Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period
- - Index PCI for stent thrombosis or chronic total occlusion
- - Need for oral anticoagulation therapy
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, 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.