Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery
NCT ID: NCT06175377
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
660 participants
INTERVENTIONAL
2024-03-30
2027-09-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Long dual Aspirin/Clopidogrel therapy
Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months
Percutaneous coronary intervention
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
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.
Follow-up visit at 1 month
At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Follow-up visit at 6 months
At 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Follow-up visit at 12 months
At 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Short dual Aspirin/Clopidogrel therapy
Patients will be treated with short dual antiplatelet aggregation for 1month
Percutaneous coronary intervention
A percutaneous coronary intervention for chronic total occlusion lesion with at least one implanted coronary stent will be performed as part of routine care.
Short dual Aspirin/Clopidogrel therapy
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.
Follow-up visit at 1 month
At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Interventions
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Percutaneous coronary intervention
A percutaneous coronary intervention for chronic total occlusion lesion with at least one implanted coronary stent will be performed as part of routine care.
Short dual Aspirin/Clopidogrel therapy
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.
Long dual Aspirin/Clopidogrel therapy
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.
Follow-up visit at 1 month
At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Follow-up visit at 6 months
At 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Follow-up visit at 12 months
At 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Eligibility Criteria
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Inclusion Criteria
* Affiliated to Social Security system.
* Signature of informed consent.
* Age \> 18 years old.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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RCAPHM23_0327
Identifier Type: -
Identifier Source: org_study_id