Thrombosis
Conditions
Keywords
Anticoagulation, Prosthetic Heart Valves, Acetylsalicylic acid, Warfarin, Thrombosis
Brief 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.
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.
Interventions
DRUGWarfarin
Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
DRUGWarfarin + 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
DRUGWarfarin + 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
DRUGObservational 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
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with prosthetic heart valve thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decreased thrombus size | 6 months | Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications |
| Same thrombus size | 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 |
| Increased thrombus size | 6 months | Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications |
| Complications | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed