Non-valvular Atrial FibrillationNCT02362659
Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry
An observational study of Non-valvular Atrial Fibrillation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 15 Nov 2018
- How long will I take part?
- 12 Months
- 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: 514 patients with non-valvular AF undergoing all-comer PCI at 11 Northern American and European hospital centers.
Who may be able to join
- Diagnosis of non-valvular atrial fibrillation during hospitalization.
- Preexisting atrial fibrillation.
- Successful all-comer percutaneous coronary intervention:
- Procedural success is defined as a reduction of residual luminal diameter stenosis to <50% without in-hospital death, AMI or the need for emergency CABG.
- Over 18 years of age
- Able to provide written informed consent
Who cannot join
- Atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis)
- Valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart valve
- Women who are of childbearing potential Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study
- Life expectancy <12 months due to non-cardiac comorbidities
- Active alcohol, drug abuse, psychosocial reasons making study participation impractical
- Severe renal insufficiency (calculated creatinine clearance < 30 mL/min) or dialysis
- Clinically overt stroke within the last 3 months
- Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI
The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry assessed whether the antithrombotic therapy intensity would vary positively with physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether an inverse association would be observed with perceived bleeding risk.
This study also evaluated the physician use of objective benefit-risk assessment scores and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF) patients undergoing PCI. Additionally the study investigated whether patient perceived relevance and accessibility of anti-platelet and anticoagulant treatment regiments would predict treatment adherence and whether non-adherence would independently influence outcome.
Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11 sites in North America and Europe. Follow-up was done via telephone by trained research coordinators at each participating site at 30 days, 6 months and 12 months.
Read the detailed description
The current AHA guidelines on AF for patients undergoing PCI are non-specific as they recommend "low-dose aspirin (less than 100 mg per d) and/or clopidogrel (75 mg per d), which may be given concurrently with anticoagulation to prevent myocardial ischemic events, but these strategies have not been thoroughly evaluated and are associated with an increased risk of bleeding.
Finding the right balance that minimizes bleeding risk and maintains anti-ischemic efficacy remains a complex and controversial clinical dilemma in these unique patients. The arrival of novel antiplatelet agents and antithrombotics on the scene has led to an exponential increase in the combinations that may be employed by clinicians in real-life situations. The sheer number of combinations means that the best APT and OAC combination based on RCT data will not be known for many years. It has therefore become imperative that the investigators strive to create better methods to gauge the comparative safety and efficacy for various antiplatelet and antithrombotic combination strategies in AF patients undergoing PCI. To the best of the investigators knowledge, no contemporary prospective registry of real-life patients with AF undergoing PCI exists or has been initiated to date. Additionally, the factors influencing physician choice of treatment strategy as well as factors predicting patient adherence in this population is largely unknown.
This is a multi-center, multinational, observational prospective registry prospective analysis of 514 patients with non-valvular AF undergoing all-comer PCI at 11 Northern American and European centers. Patients were followed for 12 months. Data was collected prospectively. All-antiplatelet and anti-thrombotic treatment regimen were at the physicians' discretion. The investigators studied various combinations of antiplatelet and antithrombotic therapies, characterized the bleeding and ischemic risk in patients with atrial fibrillation undergoing PCI and determined physician and patient centered factors influencing prescription patterns and patient adherence.
Patients with non-valvular atrial fibrillation who have undergone successful PCI were enrolled as soon as possible post procedure and no later than before discharge of the index admission. The treating physician (interventional or non-interventional cardiologist) that prescribed the anti-platelet or/and anticoagulant therapy also completed the physician questionnaire. A different, patient centered questionnaire was completed by the patient. The Principal Investigator or designee provided instructions to enrolled subjects and physicians on how to use the hand held electronic device or how to complete the paper questionnaire and clarify any questions about the questionnaires. The enrolled subjects and physicians themselves entered the responses to the questionnaire on the electronic hand held device or the paper questionnaire. Only patients with completed questionnaires were considered enrolled.
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- non-valvular, atrial fibrillation, percutaneous coronary intervention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet agent plus anticoagulant | an antithrombotic regimen comprising one single antiplatelet agent plus an anticoagulant | |
| DAPT alone | an antithrombotic regimen consisting of dual antiplatelet therapy (DAPT) alone | |
| DAPT plus anticoagulant | an antithrombotic regimen consisting of DAPT plus anticoagulant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Efficacy as measured by composite of All-cause death, non-fatal MI, stroke, stent thrombosis, clinically driven target lesion revascularization at 1 year - MACCE (major adverse cardiovascular and cerebrovascular events)
Measured: 12 months
bleeding risk
Safety as measured by bleeding according to the Bleeding Academic Research Consortium (BARC) bleeding definitions (BARC 2,3 or 5)
Measured: 12 months
Secondary outcomes (3)
Net adverse clinical events
Net adverse clinical events (NACE) - composite occurrence of all MACCE and major bleeding.
Measured: 12 months
Association between subjective and objective measures of ischemic and bleeding risk
Ischemic events assessed by CHADS, CHA2DS2-VASc is a non-valvular AF thromboembolism risk score.
Measured: 12 months
Modes of antithrombotic therapy cessation
Modes of antiplatelet and antithrombotic therapy cessation: discontinuation (physician recommended), interruption (e.g. for surgery/procedures), disruption (non-recommended)
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 posted13 Feb 2015 (estimated)
- Study startApr 2015
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 514 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Roxana Mehran, MD, Principal investigator, Icahn School of Medicine at Mount SinaiUsman Baber, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362659
- Sponsor's protocol ID
- GCO 14-1543-00002
- Other IDs
- CV185-376, PD14-03987
- Status last verified
- May 2019
- First submitted
- 9 Feb 2015
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chandrasekhar J, Mastoris I, Baber U, Sartori S, Schoos M, Bansilal S, Dangas G, Mehran R. Antithrombotic strategy variability in ATrial fibrillation and obstructive coronary disease revascularized with PCI-rationale and study design of the prospective observational multicenter AVIATOR 2 registry. Am Heart J. 2015 Dec;170(6):1234-42. doi: 10.1016/j.ahj.2015.08.023. Epub 2015 Sep 21.
PubMed 26678646Chandrasekhar J, Baber U, Sartori S, Goel R, Nicolas J, Vogel B, Snyder C, Kini A, Briguori C, Witzenbichler B, Iakovou I, Sardella G, Marzo K, DeFranco A, Stuckey T, Chieffo A, Colombo A, Shlofmitz R, Capodanno D, Dangas G, Pocock S, Mehran R. Antithrombotic strategy variability in atrial fibrillation and obstructive coronary disease revascularised with percutaneous coronary intervention: primary results from the AVIATOR 2 international registry. EuroIntervention. 2022 Oct 7;18(8):e656-e665. doi: 10.4244/EIJ-D-21-01044.
PubMed 35656720
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI
- ClinicalTrials.gov ID
- NCT02362659
- Acronym / sponsor ID
- GCO 14-1543-00002
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- non-valvular, atrial fibrillation, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2015 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 13 Feb 2015 (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.
The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry assessed whether the antithrombotic therapy intensity would vary positively with physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether an inverse association would be observed with perceived bleeding risk.
This study also evaluated the physician use of objective benefit-risk assessment scores and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF) patients undergoing PCI. Additionally the study investigated whether patient perceived relevance and accessibility of anti-platelet and anticoagulant treatment regiments would predict treatment adherence and whether non-adherence would independently influence outcome.
Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11 sites in North America and Europe. Follow-up was done via telephone by trained research coordinators at each participating site at 30 days, 6 months and 12 months.
Detailed description
The current AHA guidelines on AF for patients undergoing PCI are non-specific as they recommend "low-dose aspirin (less than 100 mg per d) and/or clopidogrel (75 mg per d), which may be given concurrently with anticoagulation to prevent myocardial ischemic events, but these strategies have not been thoroughly evaluated and are associated with an increased risk of bleeding.
Finding the right balance that minimizes bleeding risk and maintains anti-ischemic efficacy remains a complex and controversial clinical dilemma in these unique patients. The arrival of novel antiplatelet agents and antithrombotics on the scene has led to an exponential increase in the combinations that may be employed by clinicians in real-life situations. The sheer number of combinations means that the best APT and OAC combination based on RCT data will not be known for many years. It has therefore become imperative that the investigators strive to create better methods to gauge the comparative safety and efficacy for various antiplatelet and antithrombotic combination strategies in AF patients undergoing PCI. To the best of the investigators knowledge, no contemporary prospective registry of real-life patients with AF undergoing PCI exists or has been initiated to date. Additionally, the factors influencing physician choice of treatment strategy as well as factors predicting patient adherence in this population is largely unknown.
This is a multi-center, multinational, observational prospective registry prospective analysis of 514 patients with non-valvular AF undergoing all-comer PCI at 11 Northern American and European centers. Patients were followed for 12 months. Data was collected prospectively. All-antiplatelet and anti-thrombotic treatment regimen were at the physicians' discretion. The investigators studied various combinations of antiplatelet and antithrombotic therapies, characterized the bleeding and ischemic risk in patients with atrial fibrillation undergoing PCI and determined physician and patient centered factors influencing prescription patterns and patient adherence.
Patients with non-valvular atrial fibrillation who have undergone successful PCI were enrolled as soon as possible post procedure and no later than before discharge of the index admission. The treating physician (interventional or non-interventional cardiologist) that prescribed the anti-platelet or/and anticoagulant therapy also completed the physician questionnaire. A different, patient centered questionnaire was completed by the patient. The Principal Investigator or designee provided instructions to enrolled subjects and physicians on how to use the hand held electronic device or how to complete the paper questionnaire and clarify any questions about the questionnaires. The enrolled subjects and physicians themselves entered the responses to the questionnaire on the electronic hand held device or the paper questionnaire. Only patients with completed questionnaires were considered enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet agent plus anticoagulant | – | –an antithrombotic regimen comprising one single antiplatelet agent plus an anticoagulant |
| DAPT alone | – | –an antithrombotic regimen consisting of dual antiplatelet therapy (DAPT) alone |
| DAPT plus anticoagulant | – | –an antithrombotic regimen consisting of DAPT plus anticoagulant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 514 patients with non-valvular AF undergoing all-comer PCI at 11 Northern American and European hospital centers.
Key inclusion criteria (6 listed)
- Diagnosis of non-valvular atrial fibrillation during hospitalization.
- Preexisting atrial fibrillation.
- Successful all-comer percutaneous coronary intervention:
- Procedural success is defined as a reduction of residual luminal diameter stenosis to <50% without in-hospital death, AMI or the need for emergency CABG.
- Over 18 years of age
Key exclusion criteria (8 listed)
- Atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis)
- Valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart valve
- Women who are of childbearing potential Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study
- Life expectancy <12 months due to non-cardiac comorbidities
- Active alcohol, drug abuse, psychosocial reasons making study participation impractical
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse events
Time frame: 12 months
Efficacy as measured by composite of All-cause death, non-fatal MI, stroke, stent thrombosis, clinically driven target lesion revascularization at 1 year - MACCE (major adverse cardiovascular and cerebrovascular events)
bleeding risk
Time frame: 12 months
Safety as measured by bleeding according to the Bleeding Academic Research Consortium (BARC) bleeding definitions (BARC 2,3 or 5)
3 secondary outcomes
Net adverse clinical events
Time frame: 12 months
Association between subjective and objective measures of ischemic and bleeding risk
Time frame: 12 months
Modes of antithrombotic therapy cessation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Results publication: PubMed 26678646Chandrasekhar J, Mastoris I, Baber U, Sartori S, Schoos M, Bansilal S, Dangas G, Mehran R. Antithrombotic strategy variability in ATrial fibrillation and obstructive coronary disease revascularized with PCI-rationale and study design of the prospective observational multicenter AVIATOR 2 registry. Am Heart J. 2015 Dec;170(6):1234-42. doi: 10.1016/j.ahj.2015.08.023. Epub 2015 Sep 21.
- Derived from this study: PubMed 35656720Chandrasekhar J, Baber U, Sartori S, Goel R, Nicolas J, Vogel B, Snyder C, Kini A, Briguori C, Witzenbichler B, Iakovou I, Sardella G, Marzo K, DeFranco A, Stuckey T, Chieffo A, Colombo A, Shlofmitz R, Capodanno D, Dangas G, Pocock S, Mehran R. Antithrombotic strategy variability in atrial fibrillation and obstructive coronary disease revascularised with percutaneous coronary intervention: primary results from the AVIATOR 2 international registry. EuroIntervention. 2022 Oct 7;18(8):e656-e665. doi: 10.4244/EIJ-D-21-01044.
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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.
Roxana Mehran, MD principal investigator
Icahn School of Medicine at Mount Sinai
Usman Baber, MD study director
Icahn School of Medicine at Mount Sinai
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 Non-valvular Atrial Fibrillation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 7 May 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (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?
On the ClinicalTrials.gov record for NCT02362659, which also lists 2 linked publications.
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 7 May 2019.