Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Active Comparator | 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 |
|
| Warfarin + ASA 100 mg + PPI | Active Comparator | 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 |
|
| Warfarin + ASA 300 mg + PPI | Active Comparator | 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 |
|
| Observational Warfarin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosuyolu Kartal Heart Training and Research Hospital | Recruiting | Istanbul | 34844 | Turkey (Türkiye) |
Not provided
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Warfarin + ASA 100 mg + PPI | Drug | 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 |
|
| Warfarin + ASA 300 mg + PPI | Drug | 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 |
|
| Observational Warfarin | Drug | 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. |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |