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Trial record 69 of 293 for:    warfarin AND anticoagulation

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

Tracking Information
First Submitted Date  ICMJE September 12, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Decreased thrombus size [ Time Frame: 6 months ]
    Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
  • 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
  • Increased thrombus size [ Time Frame: 6 months ]
    Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis
Official Title  ICMJE Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombosis
Intervention  ICMJE
  • Drug: Warfarin
    Only warfarin is given with a target INR level of 2.5-4 to 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
  • 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
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Warfarin
  • 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
    Intervention: Drug: Warfarin + ASA 100 mg + PPI
  • 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
    Intervention: Drug: Warfarin + ASA 300 mg + PPI
  • 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.
    Intervention: Drug: Observational Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with prosthetic heart valve thrombosis

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02240953
Other Study ID Numbers  ICMJE KOSUYOLU2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Study Sponsor  ICMJE Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP