Coronary Artery Disease (CAD)Phase 3SOLOPCINCT07164859
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
A Phase 3 study testing short dual antiplatelet therapy (DAPT) duration and Standard DAPT duration in people with Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by Vincent ROULE at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Antiplatelet Therapy
- What is being tested?
- short dual antiplatelet therapy (DAPT) duration and Standard DAPT duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2026to Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Vincent ROULE, MD, PhD, +33231063975, roule-v@chu-caen.fr
Vincent ROULE, MD, PhD
About this study
Official title: Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)
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:
Read more
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
Read the detailed description
While dual antiplatelet therapy (DAPT) is the cornerstone of medical therapy after percutaneous coronary intervention (PCI), its optimal duration is still under debate. DAPT reduces the incidence of thrombotic events but exposes patients to an increased risk of bleeding strongly associated with mortality. Older age is a known predictor of bleeding risk. In the elderly, the duration of DAPT appears to be the most relevant modifiable risk factor.
Bleeding consequences triggered investigations into a further reduction in DAPT duration with the use of the newer generation drug-eluting stent (DES) but none specifically focused on elderly patients. Single antiplatelet therapy (SAPT) using a P2Y12 inhibitor after a short period of DAPT (between 1 and 3 months) has been recently tested in some studies. A meta-analysis focusing on the elderly subgroups (with cut-offs ranging between 65 and 75 years-old) showed similar rates of major bleeding and the composite ischemic endpoint but with a high level of heterogeneity highlighting the need of specific studies in this particular population. A recent large study, including a large proportion of patients ≥ 75 years and comparing SAPT after 1 month of DAPT to DAPT ≥ 3 months, showed a lower incidence of major bleedings while net adverse clinical events and major adverse cardiac events remain non-inferior. In the presence of strong P2Y12 receptor blockade, aspirin provides little additional inhibition of platelet aggregation and inhibition of hemostatic system activation has been reported to be comparable between P2Y12 inhibitor monotherapy and DAPT in healthy subjects. The low thrombogenicity of new coronary devices, potent platelet inhibition with new P2Y12 inhibitors in monotherapy and the potential life-threatening consequences of bleeding which occur mostly in the weeks following PCI support the idea of very short DAPT after PCI in elderly.
The investigators propose a multi-center randomized study to compare the safety and efficacy of very short versus standard-duration DAPT after PCI with DES in elderly patients. The investigators aim to determine whether short DAPT (for 7 days after randomization) followed by SAPT with P2Y12 inhibitor is non inferior to standard-duration DAPT regarding net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined by Bleeding Academic Research Consortium (BARC) 3 or 5) at 1 year in elderly patients undergoing PCI for acute or chronic coronary syndrome.
The investigators hypothesized that the very short strategy will be non-inferior to the standard-duration strategy. The very short strategy may allow to further reduce bleedings while maintaining the ischemic risk and may consequently become the default strategy.
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Antiplatelet Therapy, Elderly (People Aged 65 or More)
- Being tested
- short dual antiplatelet therapy (DAPT) duration, Standard DAPT duration
- Keywords
- antiplatelet therapy, percutaneous coronary intervention, elderly
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short dual antiplatelet therapy (DAPT) durationDrug
patients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone
Standard DAPT durationDrug
patients will receive DAPT for at least 3 months after randomization or longer and followed by single antiplatelet therapy
| Study group | Role | What they receive |
|---|---|---|
| standard DAPT duration | Active comparator | Patients assigned to standard DAPT duration will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for at least 3 months after randomization or longer and followed by single antiplatelet therapy (aspirin or P2Y12 inhibitor, at the discretion of the local investigator after PCI) Receives: Drug: Standard DAPT duration |
| short DAPT | Experimental | Patients assigned to short DAPT will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for 7 days (after randomization) followed by P2Y12 inhibitor alone (ticagrelor, prasugrel or clopidogrel as indicated) for 12 months Receives: Drug: short dual antiplatelet therapy (DAPT) duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
net clinical benefit
composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5
Measured: 12 months after randomization
Secondary outcomes (4)
Major or clinically relevant non-major bleeding
Major or clinically relevant non-major bleeding (BARC 2, 3 or 5), non inferiority of the experimental arm tested
Measured: 12 months
Major or clinically relevant non-major bleeding
Major or clinically relevant non-major bleeding (BARC 2, 3 or 5), superiority of the experimental arm tested
Measured: 12 months
Major cardiovascular and cerebrovascular events
a composite of all-cause death, myocardial infarction and stroke, non inferiority of the experimental arm tested
Measured: 12 months
Major bleeding (BARC 3 or 5)
Major bleeding (BARC 3 or 5), superiority of the experimental arm tested
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start3 Mar 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vincent ROULE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vincent ROULE, University Hospital, Caen
- Investigators
- Vincent ROULE, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164859
- Sponsor's protocol ID
- 2023-507545-28-00
- Other IDs
- 2023-507545-28-00, 2023
- Acronym
- SOLOPCI
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)
- ClinicalTrials.gov ID
- NCT07164859
- Acronym / sponsor ID
- SOLOPCI / 2023-507545-28-00
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Antiplatelet Therapy, Elderly (People Aged 65 or More)
- Keywords
- antiplatelet therapy, percutaneous coronary intervention, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Vincent ROULEUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
While dual antiplatelet therapy (DAPT) is the cornerstone of medical therapy after percutaneous coronary intervention (PCI), its optimal duration is still under debate. DAPT reduces the incidence of thrombotic events but exposes patients to an increased risk of bleeding strongly associated with mortality. Older age is a known predictor of bleeding risk. In the elderly, the duration of DAPT appears to be the most relevant modifiable risk factor.
Bleeding consequences triggered investigations into a further reduction in DAPT duration with the use of the newer generation drug-eluting stent (DES) but none specifically focused on elderly patients. Single antiplatelet therapy (SAPT) using a P2Y12 inhibitor after a short period of DAPT (between 1 and 3 months) has been recently tested in some studies. A meta-analysis focusing on the elderly subgroups (with cut-offs ranging between 65 and 75 years-old) showed similar rates of major bleeding and the composite ischemic endpoint but with a high level of heterogeneity highlighting the need of specific studies in this particular population. A recent large study, including a large proportion of patients ≥ 75 years and comparing SAPT after 1 month of DAPT to DAPT ≥ 3 months, showed a lower incidence of major bleedings while net adverse clinical events and major adverse cardiac events remain non-inferior. In the presence of strong P2Y12 receptor blockade, aspirin provides little additional inhibition of platelet aggregation and inhibition of hemostatic system activation has been reported to be comparable between P2Y12 inhibitor monotherapy and DAPT in healthy subjects. The low thrombogenicity of new coronary devices, potent platelet inhibition with new P2Y12 inhibitors in monotherapy and the potential life-threatening consequences of bleeding which occur mostly in the weeks following PCI support the idea of very short DAPT after PCI in elderly.
The investigators propose a multi-center randomized study to compare the safety and efficacy of very short versus standard-duration DAPT after PCI with DES in elderly patients. The investigators aim to determine whether short DAPT (for 7 days after randomization) followed by SAPT with P2Y12 inhibitor is non inferior to standard-duration DAPT regarding net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined by Bleeding Academic Research Consortium (BARC) 3 or 5) at 1 year in elderly patients undergoing PCI for acute or chronic coronary syndrome.
The investigators hypothesized that the very short strategy will be non-inferior to the standard-duration strategy. The very short strategy may allow to further reduce bleedings while maintaining the ischemic risk and may consequently become the default strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| standard DAPT duration | Active comparator | Drug: Standard DAPT durationPatients assigned to standard DAPT duration will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for at least 3 months after randomization or longer and followed by single antiplatelet therapy (aspirin or P2Y12 inhibitor, at the discretion of the local investigator after PCI) |
| short DAPT | Experimental | Drug: short dual antiplatelet therapy (DAPT) durationPatients assigned to short DAPT will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for 7 days (after randomization) followed by P2Y12 inhibitor alone (ticagrelor, prasugrel or clopidogrel as indicated) for 12 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short dual antiplatelet therapy (DAPT) durationpatients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone | Drug | short DAPT |
| Standard DAPT durationpatients will receive DAPT for at least 3 months after randomization or longer and followed by single antiplatelet therapy | Drug | standard DAPT duration |
Primary outcome
net clinical benefit
Time frame: 12 months after randomization
composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5
4 secondary outcomes
Major or clinically relevant non-major bleeding
Time frame: 12 months
Major or clinically relevant non-major bleeding
Time frame: 12 months
Major cardiovascular and cerebrovascular events
Time frame: 12 months
Major bleeding (BARC 3 or 5)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent ROULE, MD, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing short dual antiplatelet therapy (DAPT) duration and Standard DAPT duration in people with Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by Vincent ROULE at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent ROULE, MD, PhD (+33231063975, roule-v@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
net clinical benefit (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.