Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery

Not Applicable

Not yet recruiting

• Conditions: Chronic Total Occlusion
• Interventions: Procedure: Percutaneous coronary intervention; Other: Long dual Aspirin/Clopidogrel therapy; Drug: Short dual Aspirin/Clopidogrel therapy; Other: Follow-up visit at 1 month; Other: Follow-up visit at 6 months; Other: Follow-up visit at 12 months

• Registration Number: NCT06175377
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Coronary arteries are in charge of oxygen supply for the myocardium. When coronary arteries develop stenosis the coronary blood flow (i.e. oxygen flow) is reduced. Chronic total occlusion (CTO) is the extreme evolution of a coronary stenosis, which ends up to a total vessel closure.

Percutaneous coronary intervention (PCI) is the main treatment for chronic occlusions. The principle of this treatment is to implant a stent covering the whole segment of occlusion and allowing the blood to perfuse the myocardium antegradely and not retrogradely via the collateral(s). This angioplasty and stent implantation requires a dual antiplatelet therapy (aspirin associated with clopidogrel) to prevent a new thrombosis within the newly placed coronary stent.

Following the development of coronary stent (and particularly drug eluting coronary stent) new thrombosis within the implanted coronary scaffold have emerged. Dual antiplatelet therapy (DAPT) (compared to single antiplatelet therapy or anticoagulant) and initially prolonged DAPT (12 months) has offered a preventive treatment for stent thrombosis after PCI.

PCI treatment for CTOs continues to increase in France and around the world, while no dedicated study has been proposed so far regarding DAPT duration. Therefore, the general European recommendations for DAPT in chronic coronary syndrome management guidelines should be applied even though the CTO poses specific technical challenges (long and multiple stenting length for example). Even if 6 months DAPT is recommended as routine duration in chronic coronary syndrome (CCS), longer DAPT (12 months) is possible in this setting. However, the optimal duration of DAPT is not clearly demonstrated on an individual basis and each physician must adapt the DAPT duration for each single patient. A so called "ischemic / bleeding balance "guides the duration of DAPT.

This study would be the first randomized protocol to clarify the efficacy and safety of a shorter DAPT duration in the specific context of CTO PCI. It is conceivable that the technical advances which have made it possible to reduce the duration of DAPT to up to 1 month, in the cases of patients at high risk of bleeding for example, could be applicable to CTO PCI. Therefore, reducing the DAPT to 1 month, in the setting of CTO PCI, could reduce the haemorrhagic risk which should be proportional to the duration of the DAPT. Moreover, the invesitgators will evaluate the safety of short DAPT in terms of ischemic events during follow-up.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Study Start: 2024-03-30
• Primary Completion: 2027-03-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

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

Exclusion Criteria

• Dual antiplatelet therapy contra-indication
• 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);
• Patient with contraindication to aspirin and/or clopidogrel.
• No coronary stent implanted
• Age < 18years
• Patient under guardianship
• Pregnancy or breast feeding
• Prasugrel or ticagrelor use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long dual Aspirin/Clopidogrel therapy	Percutaneous coronary intervention	Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
Long dual Aspirin/Clopidogrel therapy	Long dual Aspirin/Clopidogrel therapy	Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
Long dual Aspirin/Clopidogrel therapy	Follow-up visit at 1 month	Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
Long dual Aspirin/Clopidogrel therapy	Follow-up visit at 6 months	Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
Long dual Aspirin/Clopidogrel therapy	Follow-up visit at 12 months	Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
Short dual Aspirin/Clopidogrel therapy	Percutaneous coronary intervention	Patients will be treated with short dual antiplatelet aggregation for 1month
Short dual Aspirin/Clopidogrel therapy	Short dual Aspirin/Clopidogrel therapy	Patients will be treated with short dual antiplatelet aggregation for 1month
Short dual Aspirin/Clopidogrel therapy	Follow-up visit at 1 month	Patients will be treated with short dual antiplatelet aggregation for 1month

Primary Outcome Measures

Name	Time	Method
bleeding events at 12 months	12 months	time-to-composite endpoint of bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) Classification (BARC2 to BARC5) during follow-up (12 months).
ischemic events at 12 months	12 months	time-to-composite endpoint of ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) will be recorded during follow-up (12 months).

Secondary Outcome Measures

Name	Time	Method
Major adverse ischemic clinical events (MACE)	12 months	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
Time-to-bleeding	12 months	Time-to-bleeding event defined according to Bleeding Academic Research Consortium (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.The BARC classification goes from 0 (no bleeding) to 5b (Fatal bleeding. Overt bleeding, autopsy, or imaging confirmation).
Time-to-all cause death	12 months	Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death
Compliance to drug regimen at 1 month	1 month	Compliance to drug regimen at will be assessed by telephone or during an clinical visit 1 months after the inclusion
Compliance to drug regimen at 6 months	6 months	Compliance to drug regimen at will be assessed by telephone or during an clinical visit 6 months after the inclusion
Compliance to drug regimen at 12 months	12 months	Compliance to drug regimen at will be assessed by telephone or during an clinical visit 12 months after the inclusion