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NCT07164859RecruitingPhase 3

Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI

Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if reducing the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (short treatment regimen, stopping aspirin at day 7) is as safe and efficient as the standard DAPT duration (standard treatment regimen) in elderly patients ≥ 65 years. The main questions it aims to answer are: Does the reduction of the duration of DAPT reduces rates of bleeding without increasing the risk of cardiovascular events? Researchers will compare a short treatment by DAPT (7 days, followed by single antiplatelet therapy) to a standard treatment duration by DAPT (3 to 12 months) after successful percutaneous coronary intervention with ≥ 1 drug-eluting stent. Participants will: * Take aspirin for 7 days in one group or 3 to 12 months in another group * Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge * Keep a diary of any bleeding or cardiovascular events occurring during the study period

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1700 (estimated)
First submitted
25 Aug 2025
Start date
3 Mar 2026
Primary completion date
Oct 2029
Lead sponsor
Vincent ROULE
NCT number
NCT07164859
EU CT number
2023-507545-28-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1700
  • From 3 Mar 2026 to the primary completion date, Oct 2029
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • PCI without drug-eluting stent implantation or with a bioresorbable scaffold
  • Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period
  • Need for oral anticoagulation therapy
  • Use of fibrinolytic therapy within 24 hours of PCI
  • 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 index clinical event (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)

Other illness

  • Planned coronary artery bypass grafting or cardiac surgery
  • Index clinical event PCI for stent thrombosis, in-stent restenosis or chronic total occlusion
  • Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
  • 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
  • patients with poor quality of the downstream territory with diffuse distal coronary disease

Lab values

  • 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)

Other

  • Life expectancy less than 1 year
  • Participation in another interventional trial
  • women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hysterectomy, bilateral salpingectomy or bilateral oophorectomy-

Who the study is looking for

  • 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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Besancon
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Besancon CedexFranceRecruiting
Hôpital Privé Saint-Martin Caen
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CaenFranceRecruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceRecruiting
Centre Hospitalier Public Du Cotentin
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Cherbourg-En-CotentinFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Les Hopitaux De Chartres
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Le CoudrayFranceRecruiting
Hopital Prive de L Estuaire
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Le HavreFranceRecruiting
Groupe Hospitalier du Havre
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Le HavreFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceRecruiting
Centre Hospitalier De Pau
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Pau CedexFranceRecruiting
Clinique Saint-Hilaire
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RouenFranceRecruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.