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Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Henz, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00586287
First received: December 20, 2007
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. Our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values.

The aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective.


Condition Intervention Phase
Pulmonary Embolism
Atrial Fibrillation
Hip Replacement Postoperative
Knee Replacement Postoperative
 Other: Algorithm for phenprocoumon
Other: algorithm for phenprocoumon
Drug: Phenprocoumon
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period [ Time Frame: after 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the time-course of the INR-values, the rate of excessive INR-values, defined as INR >3.5 within 10 days, the rate of minor and major bleeding complications, the length of stay, and death within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 302
Study Start Date: January 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days
 Other: Algorithm for phenprocoumon
Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm A published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.)
Other Name: Marcoumar
Experimental: B
Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days
 Other: algorithm for phenprocoumon
Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm B published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.)
Other Name: Marcoumar
Active Comparator: C
The physician chooses the loading dose of phenprocoumon according to his/her experience
 Drug: Phenprocoumon
Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
Other Name: Marcoumar

Detailed Description:

Background:

The presently available oral anticoagulants have a very narrow therapeutic range but the interindividual demands to achieve therapeutic anticoagulation (=loading dose) varies greatly. Overanticoagulation is a major cause of bleeding complications, whereas insufficient anticoagulation is associated with thromboembolic disease and possibly prolonged hospital stay. A model to predict the loading dose with phenprocoumon (Marcoumar®) is therefore highly desirable.

In a retrospective analysis of 300 inpatients (152 medical, 148 orthopedic patients) of the Cantonal Hospital of St. Gallen our group identified clinical predictors for the loading dose of phenprocoumon and two dosing algorithms were developed (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.).

In order to validate the safety and efficacy of these dosing algorithms we plan this prospective interventional study with three equally sized arms: dosing according to algorithm 1, dosing according to algorithm 2 or dosing according to the estimate of the physician (control).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive inpatients of the internal medicine and the orthopedic surgery department of the Cantonal Hospital of St. Gallen needing new onset oral anticoagulation

Exclusion Criteria:

  • Patients with prior oral anticoagulation with coumarines within less than 6 weeks,
  • patents, who received vitamin-K supplements within less than one week before the onset of oral anticoagulation,
  • patients with liver cirrhosis other than Child A,
  • pregnant women (pregnancy has to be excluded in women of childbearing age),
  • patients younger than 18 years, and
  • patients unwilling or unable to give informed consent
  • patients with (clinically diagnosed) dementia and
  • persons with insufficient German, French, Italian or English language skills)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586287

Locations
Switzerland
Cantonal Hospital St. Gallen
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Samuel Henz, MD MPH Cantonal Hospital St. Gallen Switzerland
Study Director: Wolfgang Korte, MD IKCH - Laboratory St. Gallen Switzerland
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Samuel Henz, Samuel Henz MD MPH, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00586287     History of Changes
Other Study ID Numbers: EKSG 06/022/1B, Swissmedic 2006 DR 4 2 7 9
Study First Received: December 20, 2007
Last Updated: March 29, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:
Phenprocoumon
Dosing algorithm
loading dose

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Pulmonary Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
 Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anticoagulants
Phenprocoumon
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013