Safety and efficacy of very short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy in older patients undergoing percutaneous coronary intervention

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Caen Normandie

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

6 Mar 2026 → ongoing

Decision date (initial)

2025-03-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU CAEN Normandie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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

Secondary objectives 7

1. - to determine whether short DAPT is non-inferior to standard DAPT regarding major or clinically relevant non-major bleeding (BARC 2, 3 or 5)
2. - to determine whether short DAPT is superior to standard DAPT regarding major or clinically relevant non-major bleeding (BARC 2, 3 or 5)
3. - to determine whether short DAPT is non-inferior to standard DAPT with respect to an ischemic composite endpoint (including all-cause death, myocardial infarction and stroke)
4. - to determine whether short DAPT is superior to standard DAPT regarding major bleeding (BARC 3 or 5)
5. - to determine whether short DAPT is superior to standard DAPT regarding net clinical benefit
6. - to compare the rates of the individual components of the ischemic composite endpoint between the two strategies (including all-cause death, myocardial infarction and stroke)
7. - to compare between the two strategies the rates of the following events: -cardiovascular death -stent thrombosis -Intracranial bleeding -all-cause hospitalizations -Urgent/unplanned symptoms-driven coronary revascularization

Conditions and MedDRA coding

Elderly patients ≥ 65 years successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent for acute or chronic coronary syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. - Patients ≥ 65 years
2. - 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.
3. - Randomization must be performed before the discharge from the study site.
4. - Written informed consent
5. - Social security affiliated

Exclusion criteria 15

1. - PCI without drug-eluting stent implantation or with a bioresorbable scaffold
2. - 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)
3. - Life expectancy less than 1 year
4. - Participation in another interventional trial
5. - 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
6. - Planned coronary artery bypass grafting or cardiac surgery
7. - Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period
8. - Index PCI for stent thrombosis or chronic total occlusion
9. - Need for oral anticoagulation therapy
10. - Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
11. - Use of fibrinolytic therapy within 24 hours of PCI
12. - Severe renal insufficiency (MDRD creatinine clearance < 30 ml/min/m2) and/or dialysis
13. - 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)
14. patients with poor quality of the downstream territory with diffuse distal coronary disease
15. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) non-inferiority at 1 year, H01 BARC=Bleeding Academic Research Consortium

Secondary endpoints 14

1. 1) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) non-inferiority, H02
2. - net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) evaluated as superior or not
3. - all-cause death
4. - myocardial infarction type 1, 3 or 4b (type 4b defined according ARC-2 definition)
5. - any stroke
6. - Intracranial bleeding defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury
7. - cardiovascular death (ARC-2 definition)
8. - stent thrombosis (definite or probable, ARC-2 definition)
9. - All-cause hospitalization
10. - Urgent/unplanned symptoms-driven coronary revascularization
11. Evaluation criteria of the study are hemorrhagic or thrombotic safety criteria related to the antiplatelet strategies.
12. 2) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) superiority, H03
13. 3) Major cardiovascular and cerebrovascular events (a composite of all-cause death, myocardial infarction and stroke) non-inferiority, H04
14. 4) Major bleeding (BARC 3 or 5) superiority, H05

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Caen Normandie

Sponsor organisation

Centre Hospitalier Universitaire De Caen Normandie

Address

Avenue De La Cote De Nacre, Cs 30001 Cs 30001

City

Caen Cedex 9

Postcode

14033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur coordinateur

Public contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur coordinateur

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications