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

NCT06175377 | Not Yet Recruiting

• 1 other identifier: RCAPHM23_0327
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Total Occlusion

Outcome Measures

Primary Outcomes (2)

• bleeding events at 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).

  12 months

• ischemic events at 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).

  12 months

Secondary Outcomes (6)

• Major adverse ischemic clinical events (MACE)

  12 months

• Time-to-bleeding

  12 months

• Time-to-all cause death

  12 months

• Compliance to drug regimen at 1 month

  1 month

• Compliance to drug regimen at 6 months

  6 months

Study Arms (2)

Long dual Aspirin/Clopidogrel therapy

ACTIVE COMPARATOR

Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months

Procedure: Percutaneous coronary intervention; Other: Long 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

Short dual Aspirin/Clopidogrel therapy

EXPERIMENTAL

Patients will be treated with short dual antiplatelet aggregation for 1month

Procedure: Percutaneous coronary intervention; Drug: Short dual Aspirin/Clopidogrel therapy; Other: Follow-up visit at 1 month

Interventions

Percutaneous coronary intervention PROCEDURE

A percutaneous coronary intervention for chronic total occlusion lesion with at least one implanted coronary stent will be performed as part of routine care.

Long dual Aspirin/Clopidogrel therapy; Short dual Aspirin/Clopidogrel therapy

Short dual Aspirin/Clopidogrel therapy DRUG

Aspirin will be prescribed as part of the patient's normal course of care, according to current recommendations. The second antiplatelet agent will be clopidogrel, the duration of which will vary according to the randomization group of each patient included. Patients will be treated for 1 month.

Short dual Aspirin/Clopidogrel therapy

Long dual Aspirin/Clopidogrel therapy OTHER

Aspirin will be prescribed as part of the patient's normal course of care, according to current recommendations. The second antiplatelet agent will be clopidogrel, the duration of which will vary according to the randomization group of each patient included. Patients will be treated for 6 to 12 months.

Long dual Aspirin/Clopidogrel therapy

Follow-up visit at 1 month OTHER

At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.

Long dual Aspirin/Clopidogrel therapy; Short dual Aspirin/Clopidogrel therapy

Follow-up visit at 6 months OTHER

At 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.

Long dual Aspirin/Clopidogrel therapy

Follow-up visit at 12 months OTHER

At 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.

Long dual Aspirin/Clopidogrel therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Pierre DEHARO, Dr

CONTACT

04 91 48 59 97; pierre.deharo@ap-hm.fr

Alexandra GIULIANI

CONTACT

04 91 48 28 70; alexandra.giuliani@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 18, 2023
• Study Start: March 30, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share