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Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

NCT02240953 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2014-09-16

No results posted yet for this study

Summary

Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

Conditions

Interventions

DRUG

Warfarin

Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis

DRUG

Warfarin + ASA 100 mg + PPI

100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis

DRUG

Warfarin + ASA 300 mg + PPI

In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis

DRUG

Observational Warfarin

This is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.

Sponsors & Collaborators

  • Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT02240953 on ClinicalTrials.gov