Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves

NCT02240927 | Unknown

• 1 other identifier: KOSUYOLU1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Heart; Complications, Valve, Prosthesis

Keywords

Anticoagulation; Prosthetic Heart Valves; Pregnancy; Warfarin; Thrombosis

Outcome Measures

Primary Outcomes (3)

• Successful pregnancy

  In the absence of fetal and maternal fatal or nonfatal major complications successful pregnancy

  12 month

• Maternal Complications

  * 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.

  Participants will be followed during pregnancy and postpartum period, an expected average of 12 months

• Fetal Complications

  Any congenital anomalia which may be attributed to warfarin or enoxaparine usage during pregnancy

  12 months

Study Arms (4)

Enoxaparine

ACTIVE COMPARATOR

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

Enoxaparine and 2.5 mg warfarin

ACTIVE COMPARATOR

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

Enoxaparine and 4 mg warfarin

ACTIVE COMPARATOR

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

Warfarin

ACTIVE COMPARATOR

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

Interventions

Low Molecular Weight Heparine : Enoxaparine DRUG

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).

Also known as: Clexane

Enoxaparine

Enoxaparine and 2.5 mg Warfarin DRUG

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)

Also known as: Clexane and 2.5 mg Warfarin

Enoxaparine and 2.5 mg warfarin

Enoxaparine and 4mg Warfarin DRUG

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).

Also known as: Clexane and 4 mg Warfarin

Enoxaparine and 4 mg warfarin

Warfarin DRUG

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).

Warfarin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients with prosthetic heart valves

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Kosuyolu Kartal Heart Training and Research Hospital

Istanbul, 34844, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Enoxaparin; Warfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mehmet Ozkan, Prof

  Kosuyolu Kartal Heart Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MEHMET OZKAN, PROF

CONTACT

+905322551513; memoozkan1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD., Prof., Head of Cardiology

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 16, 2014
• Study Start: January 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

TU (1)