- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706146
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT COM)
Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure, and premature death. For those with AF and other stroke risk factors, chronic anticoagulation is recommended to prevent intracardiac thrombus formation and stroke even if the AF is infrequent or short-lived. This standard of care is based partly on our inability to rapidly recognize and respond to AF recurrences which can often be brief and asymptomatic, but exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged periods of sinus rhythm where the risk of stroke is presumably low.
Recent advances in device technology and drug therapy, however, have the potential to change the way the investigators manage AF. The use of a small leadless subcutaneous implantable cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.) provides the ability to remotely and continuously evaluate a patient for AF recurrences, even episodes that are brief and asymptomatic. In addition, release of unique oral thrombin inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto]) allows for rapid onset anticoagulation within minutes to hours of a single oral dose. Together, these advances allow for continuous AF monitoring with targeted anticoagulation only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage while still protecting against stroke.
The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac monitor (Reveal XT) with remote data transmission capabilities.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5A5
- University of Western Ontario
-
-
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must meet all of the following criteria:
- Age 18 and above.
Patients with non-valvular, non-continuous AF and either:
(A) Infrequent AF episodes without a rhythm control strategy who have had no documented AF lasting > 1 hour for 3 consecutive months (the last 2 of which are on a previously implanted Reveal XT implantable cardiac monitor), or (B) Previous or current rhythm control strategy. Rhythm control strategies may include: i. Class I or Class III antiarrhythmic drugs ii. Pulmonary vein isolation iii. Post-MAZE/minimally invasive MAZE
- Current Reveal XT implant prior to study enrollment.
- Documented clinical history of symptomatic or asymptomatic paroxysmal, long-standing persistent or persistent AF prior to rhythm control initiation. The duration of AF must have been > 30 seconds as documented by an external monitor, present 12 lead ECG, or Reveal XT.
- CHADS2 score of 1 or 2
- Candidates for chronic anticoagulation with an FDA-approved non-Coumadin oral anticoagulant (dabigatran, rivaroxaban, apixaban), based on the discretion of the treating physician.
- Demonstrated ability to tolerate dabigatran 150mg/BID (if CrCl >30ml/min), rivaroxaban 15mg QD (if CrCl 15-49 ml/min) and 20mg QD (if CrCl ≥50ml/min), or apixaban 5mg BID or 2.5 mg for subjects with ≥2 of the following: age ≥ 80 years, body weight ≤60kg, serum creatinine ≥1.5 mg/dl.
- Able and willing to provide written informed consent and willing to follow instructions, attend all required study visits, and undergo all planned tests.
- Subject must be willing and able to discontinue oral anticoagulation for the purposes of this study
Exclusion Criteria:
Patients should not have any of the following criteria:
- Permanent AF
Any documented single AF episode lasting ≥ 1 hour per month over two consecutive months prior to study enrollment.
Mechanical prosthetic valves or severe valve disease.
- CHADS2 score of 0, or > 2
- Subject deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease) based on discretion of the investigator.
- Individual is pregnant, nursing, or planning to become pregnant.
- Known hypersensitivity to non-Coumadin oral anticoagulants.
- Documented prior stroke or transient ischemic attack.
- Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
Conditions associated with an increased risk of bleeding:
- Major surgery in the previous month
- Planned surgery or intervention in the next 3 months.
- History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
- Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g. by surgery)
- Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
- Hemorrhagic disorder or bleeding diathesis
- Need for anticoagulant treatment for disorders other than AF
- Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment
- Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg)
- Recent malignancy or radiation therapy (≤6 months)
- Anemia (hemoglobin <10g/dL) or thrombocytopenia (platelet count <100K/UL)
- Patients who have received an investigational drug in the past 30 days or are participating in a drug study.
- Intolerance or hypersensitivity to low dose aspirin therapy
- Life expectancy less than the expected duration of the trial due to concomitant disease.
- Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
- Inability to comply with daily data transmission requirements.
- Known history of isolated atrial flutter/atrial tachycardia without atrial fibrillation.
- More than 10 false positive atrial fibrillation events lasting > 30 minutes per month for two months prior to enrollment on a previously implantable cardiac monitor.
- Severe renal impairment (CrCl < 15 ml/min)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Non-Coumadin Oral Anticoagulant
Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
|
Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Days on Anticoagulation
Time Frame: up to 12 months
|
Assess subject anticoagulant utilization and number of days on anticoagulation
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding Incidence
Time Frame: up to 12 months
|
To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.
|
up to 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke Rate
Time Frame: 12 months
|
To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.
|
12 months
|
Overall Survival
Time Frame: 12 months
|
To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.
|
12 months
|
Major Bleeding-free Survival Rate
Time Frame: 12 months
|
To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.
|
12 months
|
Stroke-free Survival Rate
Time Frame: 12 months
|
To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandru Chicos, MD, Northwestern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00064217
- 1R34HL113404-01 (NIH)
- 7R34HL113404-03 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Non-coumadin Oral Anticoagulant
-
Ajou University School of MedicineActive, not recruitingObesity | Atrial Fibrillation | Prognosis | AnticoagulantsKorea, Republic of
-
Boehringer IngelheimCompleted
-
Icahn School of Medicine at Mount SinaiCompleted
-
InCor Heart InstituteRecruiting
-
Yonsei UniversityUnknownAtrial FibrillationKorea, Republic of
-
Azienda Ospedaliera Città della Salute e della...UnknownAtrial Fibrillation | Oral Anticoagulants | Ischem Heart Disease | Primary Coronay InterventionItaly
-
Suleyman Demirel UniversityActive, not recruitingAtrial Fibrillation | Cardioversion | Cerebrovascular StrokeTurkey
-
Peking Union Medical College HospitalRecruitingVenous Thromboembolism | Pulmonary Embolism | Anticoagulant-induced BleedingChina
-
Assiut UniversityRecruitingObesity ParadoxEgypt