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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02240927 |
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Date of registration:
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12/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves
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Scientific title:
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Comparison of Different Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves: A Randomized Clinical Trial |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02240927 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Mehmet Ozkan, Prof |
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Address:
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Telephone:
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+905322551512 |
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Email:
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memoozkan1@gmail.com |
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Affiliation:
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Name:
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MEHMET OZKAN, PROF |
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Address:
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Telephone:
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+905322551513 |
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Email:
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memoozkan1@gmail.com |
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Affiliation:
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Name:
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Mehmet Ozkan, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kosuyolu Kartal Heart Training and Research Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant patients with prosthetic heart valves
Exclusion Criteria:
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Heart; Complications, Valve, Prosthesis
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Intervention(s)
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Drug: Low Molecular Weight Heparine : Enoxaparine
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Drug: Enoxaparine and 4mg Warfarin
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Drug: Enoxaparine and 2.5 mg Warfarin
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Drug: Warfarin
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Primary Outcome(s)
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Maternal Complications
[Time Frame: Participants will be followed during pregnancy and postpartum period, an expected average of 12 months]
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Fetal Complications
[Time Frame: 12 months]
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Successful pregnancy
[Time Frame: 12 month]
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Secondary ID(s)
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KOSUYOLU1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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