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SILENT - Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by InCor Heart Institute
Sponsor:
Information provided by (Responsible Party):
Martino Martinelli Filho, InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT02004509
First received: September 24, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 the 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.


Condition Intervention Phase
Atrial Fibrillation
Drug: anticoagulant by physician criteria
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by InCor Heart Institute:

Primary Outcome Measures:
  • Stroke [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Systemic embolism [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subclinical AF rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Total mortality [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Cardiovascular mortality [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Cardiovascular hospitalization [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Bleeding rates [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2054
Study Start Date: February 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: anticoagulant by physician criteria Drug: anticoagulant by physician criteria
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.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Martino Martinelli Filho, Prof., MD, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT02004509     History of Changes
Other Study ID Numbers: SILENT
Study First Received: September 24, 2013
Last Updated: September 8, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by InCor Heart Institute:
atrial fibrillation
stroke
pacemaker
anticoagulant

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014