Study comparing single versus dual antiplatelet therapy in elderly patients or patients at risk of bleeding undergoing balloon surgery.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

26 Jan 2026 → ongoing

Decision date (initial)

2025-07-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

iVascular - Barcelona- Spain

External identifiers

EU CT number

2024-519706-13-00

ClinicalTrials.gov

NCT06535568

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of the study is to verify the superiority of SAPT vs. DAPT in terms of Net Adverse Clinical Events (NACE), defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3 or 5) at 12 months.
We thus suppose that SAPT may provide similar benefits to DAPT regarding rate of MACE, and may offer improved net clinical benefit in terms of NACE due to reduced bleeding risk.

Secondary objectives 10

1. Procedural success (correct delivery of the device with final % stenosis <30%, distal TIMI 3 flow and absence of in-hospital major adverse events)
2. The occurrence of cardiac death
3. The occurrence of death of any cause
4. The occurrence of Q-wave MI
5. The occurrence of any MI (including periprocedural MI, diagnosed according to the Fourth Definition of MI)
6. The occurrence of TLR
7. The occurrence of target vessel revascularization
8. The occurrence of any bleeding following the BARC classification
9. The occurrence of transfusion rates
10. Rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5) at 12 months

Conditions and MedDRA coding

Patients with Stable or Unstable coronary syndromes who have undergone successful PCI

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels
2. De novo coronary lesions in vessels with diameter >=2.0 and <=4.0 mm (visual estimation)
3. Stable or unstable coronary syndromes
4. Informed consent to participate in the study given by the patient or impartial witness
5. Male and female patients age ≥ 75 years or at high bleeding risk

Exclusion criteria 21

1. Stent implantation during index or recent (<6 months) procedure
2. Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated
3. Pregnancy at the time of hospitalization
4. Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer
5. ST-elevation myocardial infarction
6. Life expectancy <12 months
7. Left ventricular ejection fraction <30%
8. Visible thrombus at lesion site
9. Target lesion/vessel with any of the following characteristics: • severe and/or >270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory); • left main stem stenosis >50%; • target lesion is in the left main stem; • chronic total occlusion with anticipated necessity of retrograde approach; • lesion is in a bypass graft.
10. History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs)
11. History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage
12. Acute gastrointestinal ulcers
13. Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding)
14. Severe renal impairment (eGFR < 30 mL/min)
15. Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST > 2 x ULN or total bilirubin >1.5 x ULN)
16. Severe cardiac failure (NYHA grade III or IV)
17. Combination with methotrexate at doses of 15 mg/week or more
18. Patients with baseline neutrophil counts < 1500 cells/mm³
19. Breastfeeding women
20. Full-blown thyrotoxicosis
21. Patients with a very high risk of thrombosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint of the study will be the rate of Net Adverse Clinical Events (NACE) at 12 months, defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3, or 5), for which superiority of the SAPT arm over DAPT is hypothesized.

Secondary endpoints 12

1. Procedural success (final % stenosis <30%, distal TIMI 3 flow and absence of inhospital major adverse events); (Expected Rate: 95%)
2. Patient-oriented composite endpoint (PoCE), a composite of all-cause death, all MIs, or any repeat revascularization
3. Cardiovascular and cardiac death (Expected Rate: 1-2%)
4. All-cause death (Expected Rate: 3-5%)
5. Q-wave MI (Expected Rate: 0.5-1%)
6. Any MI (Expected Rate: 3-4%)
7. TLR (Expected Rate: 2-3%)
8. TVR (Expected Rate: 3-4%)
9. Acute vessel occlusion (ARC criteria); (Expected Rate: 4-6%)
10. Transfusion rates (Expected Rate: 1-2%)
11. Functional Status and QoL will be assessed using a validated questionnaire with EQ-5D-5L at baseline, 1 month, 6 months, and 12 months. Rate for QoL/Functional Status: (Improvement: ≥5% increase in score from baseline; Deterioration: ≥5% decrease in score from baseline; No Change: ±5% change from baseline)
12. BARC 2, 3, or 5 bleedings (superiority in study group is expected)

Investigational products

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

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Ricerca e Innovazione Cardiovascolare

Sponsor organisation

Fondazione Ricerca e Innovazione Cardiovascolare

Address

Via Ettore Ponti 49

City

Milan

Postcode

20143

Country

Italy

Scientific contact point

Organisation

Fondazione Ricerca e Innovazione Cardiovascolare

Contact name

Sara Malakouti

Public contact point

Organisation

Fondazione Ricerca e Innovazione Cardiovascolare

Contact name

Sara Malakouti

Locations

4 EU/EEA countries · 20 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 73 files

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

Application history

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