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Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

NCT00621491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2012-10-26

No results posted yet for this study

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.

Conditions

  • Cardiac Pacing
  • Complications
  • Venous Thrombosis

Interventions

DRUG

Warfarin

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Roberto Costa, MD PhD · University of Sao Paulo

  • Katia R Silva, RN PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-09-30
Completion
2008-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00621491 on ClinicalTrials.gov