Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial

NCT02004509 | Unknown Phase 4 DMC

• 1 other identifier: SILENT
• Study Type: interventional
• Target: 2,054
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients. The detection of asymptomatic AF episodes is a challenge and the real rate of occurrence of these episodes remains unknown. The rate of stroke is high among patients who have received a pacemaker and this device can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented AF. The net benefit of anticoagulant treatment is well established in patients with clinical AF but data about anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a prospective, randomized, unicentric, parallel clinical study in patients with atrioventricular pacemaker, defibrillator, or cardiac resynchronization therapy devices in sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a 1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a period of 36 months. Group I, patients will be submitted to device data collection every 2 months, while in Group II, patients will be managed conventionally. Patients from Group I with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with clinical AF of both arms. Device data from Group II patients will not be analyzed until they achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial infarction, cardiovascular hospitalization, and bleeding rates. Expected outcome: It is expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring will reduce the incidence of stroke and systemic embolism comparing to patients with non-diagnosed subclinical AF.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; stroke; pacemaker; anticoagulant

Outcome Measures

Primary Outcomes (2)

• Stroke

  Occurrence of stroke

  36 months

• Systemic embolism

  Occurrence of systemic embolism

  36 months

Secondary Outcomes (6)

• Subclinical AF rate

  36 months

• Total mortality

  36 months

• Cardiovascular mortality

  36 months

• Myocardial infarction

  36 months

• Cardiovascular hospitalization

  36 months

Study Arms (2)

anticoagulant

ACTIVE COMPARATOR

Prescription of oral anticoagulation for patients with silent AF (detected by the pacemaker).

Drug: Anticoagulant

Control

NO INTERVENTION

Patients with silent FA detected only by the pacemaker will no receive oral anticoagulation.

Interventions

Anticoagulant DRUG

Anticoagulant treatment will be started in case of subclinical atrial fibrillation (\>5,5 hours per day) be diagnosed by cardiac implantable electronic device at intervention group, or clinical atrial fibrillation in both groups.

Also known as: Oral Anticoagulant

anticoagulant

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• CHADS2 score \>=2
• Sinus rhythm
• Cardiac Implantable Electronic Device

You may not qualify if:

• Atrial fibrillation
• Severe heart valve disease
• Anticoagulation therapy
• Pregnancy

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (1)

Martino Martinelli Filho

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sergio F Siqueira, Eng

  Biomedical Eng

  STUDY DIRECTOR

Central Study Contacts

Martino Martinelli Filho, PhD, MD

CONTACT

+551126615515; martino@incor.usp.br

Sergio F Siqueira, Eng

CONTACT

+5511973083052; siqueira@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: December 9, 2013
• Study Start: February 6, 2015
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

BR (1)