Chronic Total OcclusionDAPT-CTONCT06175377
Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery
A study testing Percutaneous coronary intervention, Short dual Aspirin/Clopidogrel therapy and Long dual Aspirin/Clopidogrel therapy in people with Chronic Total Occlusion, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion
- What is being tested?
- Percutaneous coronary intervention, Short dual Aspirin/Clopidogrel therapy and Long dual Aspirin/Clopidogrel therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery: A Prospective, Multicenter, Randomized Study Comparing Two Durations of Dual Antiplatelet Therapy
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.
Read more
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
- Being tested
- Percutaneous coronary intervention, Short dual Aspirin/Clopidogrel therapy, Long dual Aspirin/Clopidogrel therapy, Follow-up visit at 1 month, Follow-up visit at 6 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
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 therapyDrug
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 therapyOther
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 monthOther
At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Follow-up visit at 6 monthsOther
At 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
Follow-up visit at 12 monthsOther
At 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
| Study group | Role | What they receive |
|---|---|---|
| Long dual Aspirin/Clopidogrel therapy | Active comparator | Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months Receives: 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 Receives: Procedure: Percutaneous coronary intervention; Drug: Short dual Aspirin/Clopidogrel therapy; Other: Follow-up visit at 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months
Secondary outcomes (6)
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
Measured: 12 months
Time-to-bleeding
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).
Measured: 12 months
Time-to-all cause death
Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death
Measured: 12 months
Compliance to drug regimen at 1 month
Compliance to drug regimen at will be assessed by telephone or during an clinical visit 1 months after the inclusion
Measured: 1 month
Compliance to drug regimen at 6 months
Compliance to drug regimen at will be assessed by telephone or during an clinical visit 6 months after the inclusion
Measured: 6 months
Compliance to drug regimen at 12 months
Compliance to drug regimen at will be assessed by telephone or during an clinical visit 12 months after the inclusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start30 Mar 2024 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175377
- Sponsor's protocol ID
- RCAPHM23_0327
- Acronym
- DAPT-CTO
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery: A Prospective, Multicenter, Randomized Study Comparing Two Durations of Dual Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT06175377
- Acronym / sponsor ID
- DAPT-CTO / RCAPHM23_0327
- Conditions
- Chronic Total Occlusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long dual Aspirin/Clopidogrel therapy | Active comparator | 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 monthsPatients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months |
| Short dual Aspirin/Clopidogrel therapy | Experimental | Procedure: Percutaneous coronary intervention, Drug: Short dual Aspirin/Clopidogrel therapy, Other: Follow-up visit at 1 monthPatients will be treated with short dual antiplatelet aggregation for 1month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionA percutaneous coronary intervention for chronic total occlusion lesion with at least one implanted coronary stent will be performed as part of routine care. | Procedure or surgery | Long dual Aspirin/Clopidogrel therapy, Short dual Aspirin/Clopidogrel therapy |
| Short dual Aspirin/Clopidogrel therapyAspirin 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. | Drug | Short dual Aspirin/Clopidogrel therapy |
| Long dual Aspirin/Clopidogrel therapyAspirin 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. | Other | Long dual Aspirin/Clopidogrel therapy |
| Follow-up visit at 1 monthAt 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized. | Other | Long dual Aspirin/Clopidogrel therapy, Short dual Aspirin/Clopidogrel therapy |
| Follow-up visit at 6 monthsAt 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized. | Other | Long dual Aspirin/Clopidogrel therapy |
| Follow-up visit at 12 monthsAt 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized. | Other | Long dual Aspirin/Clopidogrel therapy |
Primary outcome
bleeding events at 12 months
Time frame: 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
Time frame: 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).
6 secondary outcomes
Major adverse ischemic clinical events (MACE)
Time frame: 12 months
Time-to-bleeding
Time frame: 12 months
Time-to-all cause death
Time frame: 12 months
Compliance to drug regimen at 1 month
Time frame: 1 month
Compliance to drug regimen at 6 months
Time frame: 6 months
Compliance to drug regimen at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention, Short dual Aspirin/Clopidogrel therapy and Long dual Aspirin/Clopidogrel therapy in people with Chronic Total Occlusion, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre DEHARO, Dr (04 91 48 59 97, pierre.deharo@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding events at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.