Low dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomized double-blind placebo controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25820

Enrollment

200

Registered

2005-09-09

Start date

2004-11-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Treatment group: 100 microgram vitamin K for 24 weeks

2. Placebo group: placebo for 24 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients treated at the Leiden anticoagulation clinic with an indication for long-term oral anticoagulant therapy using the vitamin K antagonist phenprocoumon; 2. Age between 18 and 80 years; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Treatment by a medical specialist for liver failure; 2. Haemo- or peritoneal dialysis; 3. Pregnancy or a planned pregnancy, puerperium; 4. Any chronic condition with an expected median survival of less than 6 months an expectedinterruption of oral anticoagulant treatment of more than 1 week; 5. Self-management of oral anticoagulant therapy; 6. Other drugs affecting hemostasis (aspirin, heparin, clopidogrel).

Design outcomes

Primary

Measure	Time frame
1. Quality of anticoagulant treatment; 2. Expressed as time in therapeutic range.	—

Secondary

Measure	Time frame
1. Number of INRs in therapeutic range; 2. Bleeding and thromboembolic complications.	—

Contacts

Public ContactEva Rombouts

Leiden University Medical Center (LUMC), Department of Hematology, P.O. Box 9600

e.k.rombouts@lumc.nl+31 (0)71 5264798

Outcome results