Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status: Unknown

Conditions: Heart; Complications, Valve, Prosthesis; Pregnancy

Treatments: Drug: Enoxaparine and 2.5 mg Warfarin; Drug: Warfarin; Drug: Low Molecular Weight Heparine : Enoxaparine; Drug: Enoxaparine and 4mg Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT02240927

KOSUYOLU1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Pregnant patients with prosthetic heart valves

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Enoxaparine

Active Comparator group

Description:

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).

Treatment:

Drug: Low Molecular Weight Heparine : Enoxaparine

Enoxaparine and 2.5 mg warfarin

Active Comparator group

Description:

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)

Treatment:

Drug: Enoxaparine and 2.5 mg Warfarin

Enoxaparine and 4 mg warfarin

Active Comparator group

Description:

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).

Treatment:

Drug: Enoxaparine and 4mg Warfarin

Warfarin

Active Comparator group

Description:

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).

Treatment:

Drug: Warfarin