Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02240953
• Other study ID #: KOSUYOLU2
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2014
• Last updated: September 15, 2014
• Start date: January 2009
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with prosthetic heart valve thrombosis

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Warfarin
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
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
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
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.

Locations

Country	Name	City	State
Turkey	Kosuyolu Kartal Heart Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased thrombus size	Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications	6 months	Yes
Primary	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	Yes
Primary	Increased thrombus size	Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications	6 months	Yes
Primary	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	Yes