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Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis

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ClinicalTrials.gov Identifier: NCT02240953
Recruitment Status : Unknown
Verified September 2014 by MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
MEHMET OZKAN, 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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: Warfarin Drug: Warfarin + ASA 100 mg + PPI Drug: Warfarin + ASA 300 mg + PPI Drug: Observational Warfarin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis
Study Start Date : January 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Warfarin
Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis

Active Comparator: 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
Drug: 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

Active Comparator: 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
Drug: 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

Active Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. Decreased thrombus size [ Time Frame: 6 months ]
    Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications

  2. Same thrombus size [ Time Frame: 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

  3. Increased thrombus size [ Time Frame: 6 months ]
    Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications

  4. Complications [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with prosthetic heart valve thrombosis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240953


Locations
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Turkey
Kosuyolu Kartal Heart Training and Research Hospital Recruiting
İstanbul, Turkey, 34844
Contact: Mehmet Özkan, Prof    905322551512    memoozkan1@gmail.com   
Principal Investigator: Mehmet Özkan, Professor         
Sponsors and Collaborators
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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Responsible Party: MEHMET OZKAN, Principal Investigator, MD., Prof., Head of Cardiology, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02240953     History of Changes
Other Study ID Numbers: KOSUYOLU2
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital:
Anticoagulation
Prosthetic Heart Valves
Acetylsalicylic acid
Warfarin
Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Warfarin
Proton Pump Inhibitors
Anticoagulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics