Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

September 15, 2014 updated by: MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Three different anticoagulant treatment regimens for patients with prosthetic heart valve non-obstructive thrombosis have been described. Patients are included in each group randomly. In the first arm only warfarin is given to the patients with a target INR level of 2.5-4. In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin. In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in ombination with warfarin. Also there is an observational follow-up 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 . All patients are followed by serial transesophageal echocardiography performed every 6 months. Follow-up period is at least 6 months (range 6-60 months). Informed consent is taken from all patients.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34844
        • Recruiting
        • Kosuyolu Kartal Heart Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with prosthetic heart valve thrombosis

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Warfarin
In the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
Drug: Warfarin
Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
ACTIVE_COMPARATOR: Warfarin + ASA 100 mg + PPI
In the second arm 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 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
ACTIVE_COMPARATOR: 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: 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
ACTIVE_COMPARATOR: Observational Warfarin
This arm 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased thrombus size
Time Frame: 6 months
Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
6 months
Same thrombus size
Time Frame: 6 months
Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications
6 months
Increased thrombus size
Time Frame: 6 months
Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
6 months
Complications
Time Frame: 6 months

Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion

Nonfatal minor complication: Bleeding without need for transfusion, TIA.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (ESTIMATE)

September 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOSUYOLU2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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