Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring

NCT01706146 | Completed Phase 4 Results DMC

• 3 other identifiers: STU000642171R34HL113404-017R34HL113404-03
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; reveal xt; oral anticoagulation; dabigatran; rivaroxaban; apixaban

Outcome Measures

Primary Outcomes (1)

• Number of Days on Anticoagulation

  Assess subject anticoagulant utilization and number of days on anticoagulation

  up to 12 months

Secondary Outcomes (1)

• Bleeding Incidence

  up to 12 months

Other Outcomes (4)

• Stroke Rate

  12 months

• Overall Survival

  12 months

• Major Bleeding-free Survival Rate

  12 months

Study Arms (1)

Non-Coumadin Oral Anticoagulant

OTHER

Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.

Drug: Non-coumadin Oral Anticoagulant

Interventions

Non-coumadin Oral Anticoagulant DRUG

Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.

Also known as: Including but not limited to:, Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis)

Non-Coumadin Oral Anticoagulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Medtronic: collaborator

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

• Passman R, Leong-Sit P, Andrei AC, Huskin A, Tomson TT, Bernstein R, Ellis E, Waks JW, Zimetbaum P. Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study. J Cardiovasc Electrophysiol. 2016 Mar;27(3):264-70. doi: 10.1111/jce.12864. Epub 2015 Nov 23.

  PMID: 26511221 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; Rivaroxaban; apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Results Point of Contact

• Title: Adin-Cristian Andrei, Ph.D.
• Organization: Northwestern University

Adin-Cristian.Andrei@nm.org

312-694-0509

Study Officials

• Alexandru Chicos, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology Laboratory Bluhm Cardiovascular Institute, Northwestern Memorial Hospital

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 23, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-02

Locations

US (2); CA (1)