Phase 4
N=441
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Cryptogenic Symptomatic Transient Ischemic Attack · Cryptogenic Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00924638 ↗Enrolled (actual)
441
Serious AEs
28.6%
Results posted
Jul 2014
Primary outcome: Primary: AF Detection Rate Within 6 Months — 8.9; 1.4 percentage of participants — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Reveal® XT Insertable Cardiac Monitor (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AF Detection Rate Within 6 Months |
8.9; 1.4 | 0.0006 sig |
| SECONDARY AF Detection Rate Within 12 Months |
12.4; 2.0 | <0.0001 sig |
| SECONDARY Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack) |
7.1; 9.1 | 0.25 |
| SECONDARY Use of Oral Anticoagulation (OAC) Drugs |
14.7; 6.0 | — |
| SECONDARY Use of Antiarrhythmic Drugs |
2.0; 1.6 | — |
| SECONDARY Health Outcome as Evaluated by EQ-5D Questionnaire |
78.9; 76.3 | 0.11 |
| SECONDARY Clinical Disease Burden and Care Pathway |
10.5; 7.2 | 0.33 |
| SECONDARY Impact of Patient Assistant Use on AF Diagnosis |
14.0; 25.0; 174.8; 15.3; 92.0; 20.0 | — |
Summary
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.
Eligibility Criteria
Inclusion Criteria
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
Exclusion Criteria
- Known etiology of TIA or stroke.
- Untreated hyperthyroidism.
- Myocardial infarction less than 1 month prior to stroke or TIA.
- Coronary bypass grafting less than 1 month prior to stroke or TIA.
- Valvular disease requiring immediate surgical intervention.
- History of AF or atrial flutter.
- Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
- Permanent indication for OAC at enrollment.
- Permanent contra-indication for OAC.
- Included in another clinical trial.
- Life expectancy less than 1 year.
- Pregnant.
- Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
- Not fit, unable or unwilling to follow the required procedures of the protocol.
Data sourced from ClinicalTrials.gov (NCT00924638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.