Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Warfarin
* Drug: Warfarin + ASA 100 mg + PPI
* Drug: Warfarin + ASA 300 mg + PPI
* Drug: Observational Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with prosthetic heart valve thrombosis Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Warfarin<br>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<br>* Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis<br>|
| Active Comparator: Warfarin + ASA 100 mg + PPI<br>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<br>* 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<br>|
| Active Comparator: Warfarin + ASA 300 mg + PPI<br>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<br>* 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<br>|
| Active Comparator: Observational Warfarin<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased thrombus size | Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications | 6 months | 
| Same thrombus size | 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 | Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications | 6 months | 
| Complications | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, Prosthetic Heart Valves, Acetylsalicylic acid, Warfarin, Thrombosis