A randomised, double blind placebo controlled trial to (A) assess the optimal vitamin K dosage for supplementation, and (B) to access whether complications of anticoagulation treatment will diminish by supplementation of vitamin K: VIKS-2A / VIKS-2B. - VIKS-2A / VIKS-2B

• Conditions: Anti-coagulationtreatment with vitamine K antagonists.; MedDRA version: 9.1Level: LLTClassification code 10058768Term: Vitamin K; MedDRA version: 9.1Level: LLTClassification code 10053755Term: Vitamin K antagonist; MedDRA version: 9.1Level: HLTClassification code 10009728Term: Coagulation and bleeding analyses; MedDRA version: 9.1Level: LLTClassification code 10043607Term: Thrombosis

• Registration Number: EUCTR2007-004578-15-NL
• Lead Sponsor: Dutch Heart Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

1. Start treatment with vitamin K antagonists less then 4 weeks before inclusion.
2. Treatment with vitamin K antagonists for a minimal period of 6 months, with the therapeutic range of INR between 2.5 and 3.5.
3. Age between 18 and 85 years.
4. Measurement of the INR by the Thrombosis Service Leiden.
5. Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Treatment for liver failure.
2. Dialysys, both peritoneal as hemodialysys.
3. Pregnancy or wish to get pregnant, lactational period.
4. Known to have a chronic condition with a life expectancy of less than 6 months.
5. An expected interruption of treatment with oral anticoagulants for one week or longer.
6. Participation of the self management protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified