Antiplatelet therapy after successful percutaneous coronary intervention for chronically occluded coronary artery: A prospective, multicentre, randomized study comparing two durations of dual antiplatelet therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Marseille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

2 Dec 2024 → ongoing

Decision date (initial)

2024-05-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministere de la Sante _DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess the efficacy of a short DAPT of 1 month, in comparison with usual long DAPT (6 to 12 months) on the incidence rate over 12 months of net adverse clinical events (bleeding and/or ischemic events) in patients treated by coronary angioplasty for chronic total occlusion

Secondary objectives 5

1. -To compare the effect of two durations of dual antiplatelet therapy (short DAPT of 1 month versus usual long DAPT (6 to 12 months)) on the cumulative incidence at 12 months of haemorrhagic complications (BARC 2 to 5) in patients treated by coronary angioplasty for chronic total occlusion.
2. To compare the effect of two durations of dual antiplatelet therapy (short DAPT of 1 month versus usual long DAPT (6 to 12 months) on the overall survival rate over 12 months in patients treated by coronary angioplasty for chronic total occlusion.
3. To assess the non-inferiority of the short dual antiplatelet therapy (DAPT of 1 month) versus usual long DAPT (6 to 12 months) on the cumulative incidence at 12 months of major adverse ischemic clinical events (MACE) (ischemic stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina) in patients treated by coronary angioplasty for chronic total occlusion.
4. To compare the effect of two durations of dual antiplatelet therapy (short DAPT of 1 month versus usual long DAPT (6 to 12 months) on the treatment compliance in patients treated by coronary angioplasty for chronic total occlusion at 1-, 6- and 12-months follow-up
5. To compare the total costs incurred in each treatment group and the total quality-adjusted life years in each group over long term horizon (cost-utility analysis)

Conditions and MedDRA coding

chronically occluded coronary artery

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients who underwent a successful coronary stent implantation for chronic coronary occlusion, eligible for long-term aspirin therapy and requiring a dual antiplatelet therapy
2. Affiliated to Social Security system
3. Signature of informed consent
4. Age > 18 years old

Exclusion criteria 8

1. Dual antiplatelet therapy contra-indication
2. Patient with hypersensitivity to aspirin (or any of its excipients) and/or to any of the active substance or to any of the excipients of the investigational medical product used in this study (clopidogrel)
3. Patient with contraindication to aspirin and/or clopidogrel
4. No coronary stent implanted
5. Age<18years
6. Patient under guardianship
7. Pregnancy or breast feeding
8. Prasugrel or ticagrelor use

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event

Secondary endpoints 7

1. Time-to-bleeding event defined according to BARC classification (BARC 2 to BARC 5) over 12 months follow up, taking into account the competing risk of death from non-haemorrhagic cause, or time to last follow-up in case of no bleeding event
2. Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death
3. Major adverse ischemic clinical events (MACE): time-to-composite endpoint of ischemic stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina over 12 months follow-up, taking into account the competing risk of death from non-cardiovascular cause, or time to last follow-up in case of no MACE
4. Compliance to drug regimen at 1-, 6- and 12-months follow-up
5. Total costs in each treatment group over the one-year study period
6. Total quality-adjusted life years in each treatment group over the one-year study period
7. Long-term cost-utility ratio (expressed in terms of additional costs per quality adjusted life year gained)

Investigational products

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

Test 1

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Marseille

Sponsor organisation

Assistance Publique Hopitaux De Marseille

Address

80 Rue Brochier

City

Marseille

Postcode

13005

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Marseille

Contact name

coordinator investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Marseille

Contact name

coordinator investigator

Locations

1 EU/EEA country · 11 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 10 files

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

Application history

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