Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status: Unknown

Conditions: Thrombosis

Treatments: Drug: Warfarin + ASA 300 mg + PPI; Drug: Warfarin; Drug: Warfarin + ASA 100 mg + PPI; Drug: Observational Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT02240953

KOSUYOLU2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with prosthetic heart valve thrombosis

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

Warfarin

Active Comparator group

Description:

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

Treatment:

Drug: Warfarin

Warfarin + ASA 100 mg + PPI

Active Comparator group

Description:

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

Treatment:

Drug: Warfarin + ASA 100 mg + PPI

Warfarin + ASA 300 mg + PPI

Active Comparator group

Description:

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

Treatment:

Drug: Warfarin + ASA 300 mg + PPI

Observational Warfarin

Active Comparator group

Description:

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.

Treatment:

Drug: Observational Warfarin