NCT00621491

Brief Summary

The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 26, 2012

Status Verified

January 1, 2008

Enrollment Period

3.6 years

First QC Date

February 11, 2008

Last Update Submit

October 25, 2012

Conditions

Cardiac PacingComplicationsVenous Thrombosis

Keywords

cardiac pacingpacing complicationvenous thrombosiswarfarinanticoagulationrandomized trial

Outcome Measures

Primary Outcomes (1)

  • Incidence of venous obstructions observed by digital subtraction venography

    Six months

Secondary Outcomes (1)

  • Safety of anticoagulant therapy, morbidity and overall mortality

    Six months

Study Arms (1)

1

PLACEBO COMPARATOR

Single daily dose of Placebo during six months

Drug: Warfarin

Interventions

WarfarinDRUG

Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months

Also known as: oral anticoagulants
1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices
  • left ventricular ejection fraction ≤0.40 and/or
  • previous transvenous temporary leads ipsilateral to the permanent device implant

You may not qualify if:

  • history of venous thromboembolism
  • atrial fibrillation
  • coagulopathy or platelet disorder
  • malignancy
  • gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months
  • abnormal prothrombin time (PT)or an international normalized ratio (INR) \>40%, or treated with oral anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (2)

  • Costa R, Da Silva KR, Rached R, Martinelli Filho M, Carnevale FC, Moreira LF, Stolf NA. Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S247-51. doi: 10.1111/j.1540-8159.2008.02295.x.

    PMID: 19250106RESULT

  • Silva KR, Costa R, Abi Rached R, Martinelli Filho M, Caldas JG, Carnevale FC, Moreira LF, Stolf NA. Warfarin prevents venous obstruction after cardiac devices implantation in high-risk patients: partial analysis. Rev Bras Cir Cardiovasc. 2008 Oct-Dec;23(4):542-9. doi: 10.1590/s0102-76382008000400015. English, Portuguese.

    PMID: 19229428RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

WarfarinAnticoagulants

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Roberto Costa, MD PhD

    University of Sao Paulo

    STUDY CHAIR

  • Katia R Silva, RN PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD, Associate Professor of Cardiovascular Surgery

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 22, 2008

Study Start

February 1, 2004

Primary Completion

September 1, 2007

Study Completion

July 1, 2008

Last Updated

October 26, 2012

Record last verified: 2008-01

Locations

BR(1)