Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA)Phase 4SHORT RUN AFNCT05487950
Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk
A Phase 4 study testing Rivaroxaban group in people with Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The primary objective of the Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA)
- What is being tested?
- Rivaroxaban group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2023to 5 Apr 2027
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients ≥ 65 years old
- Diagnosis of excessive supraventricular ectopy activity defined as ≥ 1% PAC / 24 h or any atrial runs ≥ 20 PACs on a 24-hour Holter ECG monitoring (the indication for the Holter will be let at the discretion of the doctor according to international guidelines indication)
- High risk embolism defined by a CHA2DS2VASC score ≥ 3
- Written consent from patient
- Patients able to attend consultations and Cerebral MRI at baseline and 24 months at the participating centre.
- Ability to understand and comply with the study protocol
- Affiliation of social security regime
Who cannot join
- According to the SmPC, any contraindication to Rivaroxaban (particularly patients with ongoing major bleeding, vascular complication, prior haemorrhagic stroke or over recent stroke) or one of its excipients.
- Inability to perform cerebral MRI
- Life expectancy <24 months
- History of major hemorrhage after taking Rivaroxaban
- Documented atrial fibrillation or any other indication for oral anticoagulation
- Patients with previous documented AF
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- Valvular congenital heart disease
- Anticoagulant agents in the month prior to the inclusion visit
- Acute coronary syndrome, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery) or in the past 30 days
- Requires long-term antiplatelet therapy other than aspirin (i.e., patient requires any platelet aggregation inhibitor in addition to study treatment, in particular, the combination of two platelet aggregation inhibitors)
- Ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
- Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin)
- Participants considered by the investigator to be unsuitable for the study for any of the following reasons:Patient refuse the treatment with rivaroxaban or anticipated to have poor compliance on study drug treatment or Unwilling to attend study follow-up visits
- Cancer or other life threatening conditions
- Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
- Conditions associated with an increased risk of bleeding:
- Major surgery within the previous month
- Planned surgery or intervention within the next 3 months
- History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
- Gastrointestinal hemorrhage within the past year
- Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
- Hemorrhagic disorder or bleeding diathesis
- Need for anticoagulant treatment of disorders other than atrial fibrillation
- Fibrinolytic agents within 48 hours of study entry
- Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg)
- Recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years
- Severe renal impairment (estimated creatinine clearance <30 mL/min or less)
- Active infective endocarditis
- Active liver disease, including but not limited to, associated or not with coagulopathy and a clinically significant risk of bleeding, including cirrhotic patients with a Child Pugh class B or C score.
- Persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range
- Known active hepatitis C (positive HCV RNA)
- Known active hepatitis B (HBs antigen +, anti HBc IgM +)
- Known active hepatitis A
- Anemia (hemoglobin level less than 110 g/L) or thrombocytopenia (platelet count less than 150 X 109/L)
- Patients who have received an investigational drug in the past 30 days
- Patients considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
- Patient with cardiac prosthetic devices : Reveal, pace-maker, automatic implantable defibrillator
- Participation in another interventional clinical trial
- Patient on AME (state medical aid)
- Persons under psychiatric care
- Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)Patients deprived of their liberty by a judicial or administrative decision
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
The primary objective of the Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events.
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
Read the detailed description
Patients with atrial fibrillation (AF) (> 30 consecutive seconds of arrhythmia) and high risk embolism meaning CHA2DS2VASC score ≥2 are candidate for long term oral anticoagulation. In addition, patients with excessive supraventricular ectopies or short atrial runs (ESVEA) but no documented AF are also at higher risk of systemic embolism compared to normal population. ESVEA is a frequent clinical situation observed approximately in up to 15% on systematic 24-hour Holter ECG in patients over 65 years old with cardiovascular risk factors. In addition, it is associated with a higher risk of peripheral arterial thromboembolism. However, it remains unclear if this former population could benefit from long-term oral anticoagulation.
To date no other studies have evaluated the effect of anticoagulation for patients with excessive atrial ectopies or short atrial runs. Also, to our knowledge, no study evaluating this problematic is ongoing. This population is actually not treated but in real clinical practice, patients with high CHA2DS2VASC score presenting with ESVEA could be candidate for oral anticoagulation. If it is demonstrated that patients with ESVEA and CHA2DS2VASC score ≥ 3 could benefit from oral anticoagulation and particularly new oral anticoagulants, it would change the everyday practice of cardiologist or gerontologist.
Our hypothesis is that long term anticoagulation with rivaroxaban could reduce drastically (50%, comparable with its effect during AF) the incidence of stroke or other thromboembolism events compared to standard of care (SOC), with a possible but moderate increased risk of bleeding compared to SOC that should remain acceptable compared to the reduction of stroke (net clinical benefit).
In this study, the study also attempt to describe the clinical course of patients with ESVEA in terms of global cardiovascular events, occurrence of documented atrial fibrillation or cognitive decline with an everyday practice follow-up.
- Being tested
- Rivaroxaban group
- Keywords
- atrial fibrillation, RIVAROXABAN, embolism, short atrial runs (ESVEA)
- Medical subject headings
- Atrial Fibrillation, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban groupDrug
Patients assigned in the Rivaroxaban group will receive 15 mg once day or 10 mg if dosage modification is needed due to renal insufficiency (Creatinine clairance calculated with the Cockroft formula between 30 or 49 ml/min).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients in the Rivaroxaban group will receive Rivaroxaban at the dose of 15 mg once daily ((or 10 mg if renal insufficiency) during 2 years. Receives: Drug: Rivaroxaban group |
| group control | No intervention | Patients in the control group will be followed according to the standard of care (SOC) chosen by the investigator during 2 years. Additions or changes to SOC are allowed during the patient participation in the study based on patient status and evolution (with the exception of the use of anticoagulant therapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of first ischemic stroke or peripheral embolism
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
Measured: during 28 months follow-up
incidence of major bleeding at any site in the body
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
Measured: 2-year follow-up.
Secondary outcomes (1)
the incidence of documented atrial fibrillation
the incidence of documented atrial fibrillation diagnosed from patient symptoms or systematic 24 hours ECG Holter performed at 2-year follow-up.
Measured: 2-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start5 Apr 2023 (estimated)
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase III prospective superiority randomized open-label multicenter study with 2 parallel groups (control vs. experimental group). Our study will test the superiority of anticoagulation treatment with Rixaroxaban (experimental group) compared to SOC (control group). This is a phase III prospective superiority randomized, open-label multicenter study with 2 parallel groups (control vs. experimental group). Patients with excessive supraventricular ectopies or short atrial runs (ESVEA) defined as ≥ 1% PAC /24 hours or any atrial runs ≥ 20 PACs on a 24-hour Holter ECG monitoring and CHA2DS2VASC score ≥ 3
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487950
- Sponsor's protocol ID
- APHP200002
- Acronym
- SHORT RUN AF
- Status last verified
- Mar 2023
- First submitted
- 2 Aug 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk
- ClinicalTrials.gov ID
- NCT05487950
- Acronym / sponsor ID
- SHORT RUN AF / APHP200002
- Keywords
- atrial fibrillation, RIVAROXABAN, embolism, short atrial runs (ESVEA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Apr 2023 (estimated)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 4 Aug 2022 (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.
The primary objective of the Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events.
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
Detailed description
Patients with atrial fibrillation (AF) (> 30 consecutive seconds of arrhythmia) and high risk embolism meaning CHA2DS2VASC score ≥2 are candidate for long term oral anticoagulation. In addition, patients with excessive supraventricular ectopies or short atrial runs (ESVEA) but no documented AF are also at higher risk of systemic embolism compared to normal population. ESVEA is a frequent clinical situation observed approximately in up to 15% on systematic 24-hour Holter ECG in patients over 65 years old with cardiovascular risk factors. In addition, it is associated with a higher risk of peripheral arterial thromboembolism. However, it remains unclear if this former population could benefit from long-term oral anticoagulation.
To date no other studies have evaluated the effect of anticoagulation for patients with excessive atrial ectopies or short atrial runs. Also, to our knowledge, no study evaluating this problematic is ongoing. This population is actually not treated but in real clinical practice, patients with high CHA2DS2VASC score presenting with ESVEA could be candidate for oral anticoagulation. If it is demonstrated that patients with ESVEA and CHA2DS2VASC score ≥ 3 could benefit from oral anticoagulation and particularly new oral anticoagulants, it would change the everyday practice of cardiologist or gerontologist.
Our hypothesis is that long term anticoagulation with rivaroxaban could reduce drastically (50%, comparable with its effect during AF) the incidence of stroke or other thromboembolism events compared to standard of care (SOC), with a possible but moderate increased risk of bleeding compared to SOC that should remain acceptable compared to the reduction of stroke (net clinical benefit).
In this study, the study also attempt to describe the clinical course of patients with ESVEA in terms of global cardiovascular events, occurrence of documented atrial fibrillation or cognitive decline with an everyday practice follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase III prospective superiority randomized open-label multicenter study with 2 parallel groups (control vs. experimental group). Our study will test the superiority of anticoagulation treatment with Rixaroxaban (experimental group) compared to SOC (control group). This is a phase III prospective superiority randomized, open-label multicenter study with 2 parallel groups (control vs. experimental group). Patients with excessive supraventricular ectopies or short atrial runs (ESVEA) defined as ≥ 1% PAC /24 hours or any atrial runs ≥ 20 PACs on a 24-hour Holter ECG monitoring and CHA2DS2VASC score ≥ 3
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Rivaroxaban groupPatients in the Rivaroxaban group will receive Rivaroxaban at the dose of 15 mg once daily ((or 10 mg if renal insufficiency) during 2 years. |
| group control | No intervention | –Patients in the control group will be followed according to the standard of care (SOC) chosen by the investigator during 2 years. Additions or changes to SOC are allowed during the patient participation in the study based on patient status and evolution (with the exception of the use of anticoagulant therapy). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 65 years old
- Diagnosis of excessive supraventricular ectopy activity defined as ≥ 1% PAC / 24 h or any atrial runs ≥ 20 PACs on a 24-hour Holter ECG monitoring (the indication for the Holter will be let at the discretion of the doctor according to international guidelines indication)
- High risk embolism defined by a CHA2DS2VASC score ≥ 3
- Written consent from patient
- Patients able to attend consultations and Cerebral MRI at baseline and 24 months at the participating centre.
Key exclusion criteria (41 listed)
- According to the SmPC, any contraindication to Rivaroxaban (particularly patients with ongoing major bleeding, vascular complication, prior haemorrhagic stroke or over recent stroke) or one of its excipients.
- Inability to perform cerebral MRI
- Life expectancy <24 months
- History of major hemorrhage after taking Rivaroxaban
- Documented atrial fibrillation or any other indication for oral anticoagulation
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 |
|---|---|---|
| Rivaroxaban groupPatients assigned in the Rivaroxaban group will receive 15 mg once day or 10 mg if dosage modification is needed due to renal insufficiency (Creatinine clairance calculated with the Cockroft formula between 30 or 49 ml/min). | Drug | experimental group |
Primary outcome
incidence of first ischemic stroke or peripheral embolism
Time frame: during 28 months follow-up
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
incidence of major bleeding at any site in the body
Time frame: 2-year follow-up.
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
1 secondary outcome
the incidence of documented atrial fibrillation
Time frame: 2-year follow-up.
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 28 Mar 2023.
- Individual participant dataSharing planned: No
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 Phase 4 study testing Rivaroxaban group in people with Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA), run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 41 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 28 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nicolas LELLOUCHE, MD, PhD (0)1 49 81 43 50 ext. 33, nicolas.lellouche@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of first ischemic stroke or peripheral embolism (time frame: during 28 months follow-up). 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 28 Mar 2023.