Percutaneous Coronary InterventionNCT03012906
Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions
An observational study of Percutaneous Coronary Intervention, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- the prevalence of ischemic events
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jul 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients undergoing percutaneous coronary intervention (PCI)
Who may be able to join
- age over 18 years old
- signed informed consent
- requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
- FA requiring chronic anticoagulation (CHA2DS2-VASc >1, except women with a score =1).
Who cannot join
- pregnancy or lactation
- age <18 or not able to give an informed consent
- no informed consent
- no health insurance
- prisoners
- contra indication to antiplatelet therapy
Show all 14Show fewer
- intra cardiac thrombus
- active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)
- severe kidney failure (eGFR < 30 mL/min/1.73 m²)
- severe hepatic failure (Child-Pugh class B or C)
- contra indication to OAC or VKA
- hypertrophic myocardiopathy
- valvular prosthesis
- history of peptic ulcer
Trial locations and contacts
1 site in 1 country.
Laurent bonello contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
About this study
Official title: Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).
Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.
Read more
Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.
These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.
The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- the prevalence of ischemic events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the prevalence of ischemic eventsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths
Measured: 2 years
Number of myocardial infarctions
Measured: 2 years
Number of strokes
Measured: 2 years
Secondary outcomes (1)
The prevalence of bleeding events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hopitaux De MarseilleLaurent bonello, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012906
- Sponsor's protocol ID
- 2016-16
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT03012906
- Acronym / sponsor ID
- 2016-16
- Conditions
- Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).
Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.
Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.
These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.
The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing percutaneous coronary intervention (PCI)
Key inclusion criteria (4 listed)
- age over 18 years old
- signed informed consent
- requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
- FA requiring chronic anticoagulation (CHA2DS2-VASc >1, except women with a score =1).
Key exclusion criteria (14 listed)
- pregnancy or lactation
- age <18 or not able to give an informed consent
- no informed consent
- no health insurance
- prisoners
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 |
|---|---|---|
| the prevalence of ischemic events | Other | – |
Primary outcome
Number of deaths
Time frame: 2 years
Number of myocardial infarctions
Time frame: 2 years
Number of strokes
Time frame: 2 years
1 secondary outcome
The prevalence of bleeding events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: No
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ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
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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. This study is not recruiting at the moment.
Laurent bonello contact
Catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
Laurent bonello principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 14 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent bonello (laurent.bonello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths (time frame: 2 years). The study lists 3 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 6 Jan 2017.