Very short DAPT after PCI in older adults
Official title: Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)
Run by University Hospital, Caen · NCT07164859 · Data updated 2026-11-12
This trial tests whether stopping aspirin after 7 days of dual antiplatelet therapy is as safe and effective as continuing DAPT for 3 to 12 months in people 65 and older who had a PCI with drug-eluting stents.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 1700 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | October 2029 |
| Study ends | October 2029 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07164859 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Eligible participants are adults aged 65 and older who have successfully undergone PCI with at least one drug-eluting stent and meet all inclusion criteria.
✕Probably not a fit
Patients who experience higher rates of ischemic events with shorter DAPT or who require planned surgeries during follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this phase 3 study, older adults (≥65) who have undergone PCI with at least one drug-eluting stent are randomized to either a very short DAPT course (7 days of DAPT followed by single antiplatelet therapy) or a standard DAPT duration (3–12 months). The primary questions are whether the short DAPT approach reduces bleeding without increasing cardiovascular events. Participants are contacted by phone at multiple time points up to 12 months and maintain a diary of bleeding and cardiovascular events. The study focuses on balancing bleeding risk with ischemic protection in an elderly population where DAPT duration is a key modifiable risk factor.
Why it matters
Potential benefit: If successful, the shorter DAPT strategy could reduce bleeding complications and simplify post-PCI antiplatelet management for older patients.
How similar studies have gone: Some prior studies and meta-analyses in elderly subgroups suggested comparable ischemic risk with shorter DAPT, but results were heterogeneous, underscoring the need for a dedicated elderly-focused trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * PCI without drug-eluting stent implantation or with a bioresorbable scaffold * 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 clinical event PCI for stent thrombosis, in-stent restenosis or chronic total occlusion * Need for oral anticoagulation therapy * 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) * 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) * 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 * 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 -hysterectomy, bilateral salpingectomy or bilateral oophorectomy-
Where it's running
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Caen University Hospital
Caen, France Recruiting
Study contacts
- Principal investigator: Vincent ROULE, MD, PhD — University Hospital, Caen
- Study coordinator: Vincent ROULE, MD, PhD
- Email: roule-v@chu-caen.fr
- Phone: +33231063975
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.