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Trial record 34 of 291 for:    warfarin AND anticoagulation

Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves

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ClinicalTrials.gov Identifier: NCT02240927
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:
Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

Condition or disease Intervention/treatment Phase
Pregnancy Heart; Complications, Valve, Prosthesis Drug: Low Molecular Weight Heparine : Enoxaparine Drug: Enoxaparine and 2.5 mg Warfarin Drug: Enoxaparine and 4mg Warfarin Drug: Warfarin Not Applicable

Detailed Description:
Four different anticoagulant treatment regimens for pregnant patients with prosthetic heart valves have been described. In the first arm warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day which is monitored by weekly anti-Xa levels (between 0.7-1.2) during the first trimester and followed by only warfarin after first trimester. In the second arm, if the patient's warfarin consumption is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester combined with enoxaparine in 1mg/kg dose twice a day; adjusted by measurements of anti-Xa levels (between 0.5-1) weekly until the end of 12th week of pregnancy . In the third arm warfarin dose is decreased to 4 mg during the first trimester combined with enoxaparine given in a similar manner. If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy in the 4th arm. All patients are followed by serial transesophageal echocardiography performed at 0,3,6 and 9. months of pregnancy. Informed consent is taken from all patients. After delivery the babies are examined by a experinced pediatrician and pediatric cardiologist for any congenital anomalies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Different Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves: A Randomized Clinical Trial
Study Start Date : January 2010
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Enoxaparine
During first trimester, warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day. Dose is adjusted according to Anti Factor Xa levels (between 0.7-1.2). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
Drug: Low Molecular Weight Heparine : Enoxaparine
During first trimester, warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day. Dose is adjusted according to Anti Factor Xa levels (between 0.7-1.2). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
Other Name: Clexane

Active Comparator: Enoxaparine and 2.5 mg warfarin
If the patient's therapeutic warfarin dose is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1.0). Full dose warfarin is continued after first trimester and dose is regulated according to INR (between 2.5-4)
Drug: Enoxaparine and 2.5 mg Warfarin
If the patient's therapeutic warfarin dose is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4)
Other Name: Clexane and 2.5 mg Warfarin

Active Comparator: Enoxaparine and 4 mg warfarin
If the patient's warfarin consumption dose is more than 5 mg before pregnancy, warfarin dose is decreased to 4 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
Drug: Enoxaparine and 4mg Warfarin
If the patient's warfarin consumption dose is more than 5 mg before pregnancy, warfarin dose is decreased to 4 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
Other Name: Clexane and 4 mg Warfarin

Active Comparator: Warfarin
If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy and the dose is adjusted according to INR level (between 2.5-4).
Drug: Warfarin
If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy and the dose is adjusted according to INR level (between 2.5-4).




Primary Outcome Measures :
  1. Successful pregnancy [ Time Frame: 12 month ]
    In the absence of fetal and maternal fatal or nonfatal major complications successful pregnancy

  2. Maternal Complications [ Time Frame: Participants will be followed during pregnancy and postpartum period, an expected average of 12 months ]
    • Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, abortus, placental hemorrhage, Assessment of an increase in thrombus burden more than 50% and/or progression of PVT obstruction by transesophageal echocardiography.
    • Nonfatal minor complication: Bleeding without need for transfusion, TIA.

  3. Fetal Complications [ Time Frame: 12 months ]
    Any congenital anomalia which may be attributed to warfarin or enoxaparine usage during pregnancy



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant patients with prosthetic heart valves

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): NCT02240927


Contacts
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Contact: MEHMET OZKAN, PROF +905322551513 memoozkan1@gmail.com

Locations
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Turkey
Kosuyolu Kartal Heart Training and Research Hospital Recruiting
Istanbul, Turkey, 34844
Contact: Mehmet Ozkan, Prof    +905322551512    memoozkan1@gmail.com   
Principal Investigator: Mehmet Ozkan, Prof         
Sponsors and Collaborators
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Investigators
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Principal Investigator: Mehmet Ozkan, Prof Kosuyolu Kartal Heart Training 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: NCT02240927     History of Changes
Other Study ID Numbers: KOSUYOLU1
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
Pregnancy
Warfarin
Thrombosis
Additional relevant MeSH terms:
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Enoxaparin
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action