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NCT01706146 · ClinicalTrials.gov registry record · Phase 4
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
NCT01706146 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 59 participants.
The verdict
NCT01706146, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
Study 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.
Interventions
- DRUG Non-coumadin Oral Anticoagulant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01706146
The ClinicalTrials.gov registry entry for NCT01706146 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Non-coumadin Oral Anticoagulant is the first listed.
NCT01706146 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01706146 about?
NCT01706146 is a clinical study titled "Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring". 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 prev...
What is the current status of trial NCT01706146?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2012-10. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01706146?
The interventions under investigation include: Non-coumadin Oral Anticoagulant (DRUG).
Who is sponsoring clinical trial NCT01706146?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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