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Randomized On-X Anticoagulation Trial

NCT00291525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 977

Last updated 2024-12-24

Study results available
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Summary

Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.

Conditions

  • Heart Valve Disease

Interventions

DEVICE

On-X valve using reduced anticoagulation

Valve replacement with antiplatelet agents or lowered warfarin

DEVICE

On-X Valve with Standard warfarin Therapy

Valve replacement with standard dosage warfarin

Sponsors & Collaborators

  • Clinipace Worldwide

    collaborator INDUSTRY

  • Acelis Connected Health

    collaborator UNKNOWN

  • WCG IRB

    collaborator UNKNOWN

  • Avania

    collaborator INDUSTRY

  • On-X Life Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • John Puskas, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-06
Primary Completion
2023-08-08
Completion
2023-12-29

Countries

  • United States
  • Canada

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 NCT00291525 on ClinicalTrials.gov