Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

Not Applicable

• Conditions: Thrombosis
• Interventions: Drug: Warfarin + ASA 300 mg + PPI; Drug: Warfarin + ASA 100 mg + PPI; Drug: Observational Warfarin; Drug: Warfarin

• Registration Number: NCT02240953
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Last Update Submitted: 2014-09-15
• Study First Posted: 2014-09-16
• Last Update Posted: 2014-09-16
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients with prosthetic heart valve thrombosis

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warfarin + ASA 300 mg + PPI	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
Warfarin + ASA 100 mg + PPI	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
Observational Warfarin	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.
Warfarin	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

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Kosuyolu Kartal Heart Training and Research Hospital; 🇹🇷 İstanbul, Turkey