Assessing anticoagulant therapy for subclinical atrial fibrillation detection
SILENT - Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial
PHASE4 · InCor Heart Institute · NCT02004509
This study is testing if giving blood thinners to patients with hidden atrial fibrillation can reduce their risk of stroke compared to regular care.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2054 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | InCor Heart Institute (other) |
| Locations | 1 site (São Paulo, Sao Paulo) |
| Trial ID | NCT02004509 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of anticoagulant therapy on patients with subclinical atrial fibrillation (AF) detected by cardiac implantable electronic devices (CIEDs). It aims to determine how intensive monitoring of asymptomatic AF episodes can influence the incidence of stroke and systemic embolism. Patients with an atrioventricular pacemaker or similar devices and a CHADS2 score of 2 or higher will be randomized into two groups: one receiving intensive monitoring and the other receiving routine care. The study will follow participants for 24 months to assess outcomes related to stroke and thromboembolic events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a CHADS2 score of 2 or higher who have a cardiac implantable electronic device and are in sinus rhythm.
Not a fit: Patients currently experiencing atrial fibrillation or those on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for strokes in patients with subclinical atrial fibrillation.
How similar studies have performed: While the approach of using CIEDs for monitoring subclinical AF is innovative, there is limited data on the effectiveness of anticoagulation in this specific context, making this study relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years * CHADS2 score \>=2 * Sinus rhythm * Cardiac Implantable Electronic Device Exclusion Criteria: * Atrial fibrillation * Severe heart valve disease * Anticoagulation therapy * Pregnancy
Where this trial is running
São Paulo, Sao Paulo
- Martino Martinelli Filho — São Paulo, Sao Paulo, Brazil (RECRUITING)
Study contacts
- Study coordinator: Martino Martinelli Filho, PhD, MD
- Email: martino@incor.usp.br
- Phone: +551126615515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, atrial fibrillation, stroke, pacemaker, anticoagulant