Pulmonary EmbolismPhase 4NCT00586287
Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon
A Phase 4 study testing Algorithm for phenprocoumon and Phenprocoumon in people with Pulmonary Embolism and Atrial Fibrillation, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Atrial Fibrillation, Hip Replacement Postoperative
- What is being tested?
- Algorithm for phenprocoumon and Phenprocoumon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive inpatients of the internal medicine and the orthopedic surgery department of the Cantonal Hospital of St. Gallen needing new onset oral anticoagulation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon
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.
Read the 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).
- Conditions
- Pulmonary Embolism, Atrial Fibrillation, Hip Replacement Postoperative, Knee Replacement Postoperative
- Being tested
- Algorithm for phenprocoumon, Phenprocoumon
- Keywords
- Phenprocoumon, Dosing algorithm, loading dose
- Medical subject headings
- Pulmonary Embolism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm for phenprocoumonOther
Also called Marcoumar
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.)
algorithm for phenprocoumonOther
Also called Marcoumar
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.)
PhenprocoumonDrug
Also called Marcoumar
Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days Receives: Other: Algorithm for phenprocoumon |
| B | Experimental | Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days Receives: Other: algorithm for phenprocoumon |
| C | Active comparator | The physician chooses the loading dose of phenprocoumon according to his/her experience Receives: Drug: Phenprocoumon |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period
Measured: after 30 days
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Henz, Cantonal Hospital of St. Gallen
- Investigators
- Samuel Henz, MD MPH, Principal investigator, Cantonal Hospital of St. GallenWolfgang Korte, MD, Study director, IKCH - Laboratory St. Gallen Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586287
- Sponsor's protocol ID
- EKSG 06/022/1B
- Other IDs
- Swissmedic 2006 DR 4 2 7 9
- Status last verified
- Mar 2012
- First submitted
- 20 Dec 2007
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5. doi: 10.1016/j.thromres.2007.01.013. Epub 2007 Mar 12. No abstract available.
PubMed 17350082Caduff Good A, Nobel D, Krahenbuhl S, Geisen C, Henz S. Randomised trial of a clinical dosing algorithm to start anticoagulation with phenprocoumon. Swiss Med Wkly. 2013 Jan 8;143:w13709. doi: 10.4414/smw.2013.13709. eCollection 2013.
PubMed 23299853
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon
- ClinicalTrials.gov ID
- NCT00586287
- Acronym / sponsor ID
- EKSG 06/022/1B
- Conditions
- Pulmonary Embolism, Atrial Fibrillation, Hip Replacement Postoperative, Knee Replacement Postoperative
- Keywords
- Phenprocoumon, Dosing algorithm, loading dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Algorithm for phenprocoumonAlgorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days |
| B | Experimental | Other: algorithm for phenprocoumonAlgorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days |
| C | Active comparator | Drug: PhenprocoumonThe physician chooses the loading dose of phenprocoumon according to his/her experience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive inpatients of the internal medicine and the orthopedic surgery department of the Cantonal Hospital of St. Gallen needing new onset oral anticoagulation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm for phenprocoumonAlso: MarcoumarDosing 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 | A |
| algorithm for phenprocoumonAlso: MarcoumarDosing 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 | B |
| PhenprocoumonAlso: MarcoumarDosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician | Drug | C |
Primary outcome
rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period
Time frame: after 30 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Background: PubMed 17350082Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5. doi: 10.1016/j.thromres.2007.01.013. Epub 2007 Mar 12. No abstract available.
- Derived from this study: PubMed 23299853Caduff Good A, Nobel D, Krahenbuhl S, Geisen C, Henz S. Randomised trial of a clinical dosing algorithm to start anticoagulation with phenprocoumon. Swiss Med Wkly. 2013 Jan 8;143:w13709. doi: 10.4414/smw.2013.13709. eCollection 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Henz, MD MPH principal investigator
Cantonal Hospital of St. Gallen
Wolfgang Korte, MD study director
IKCH - Laboratory St. Gallen Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Algorithm for phenprocoumon and Phenprocoumon in people with Pulmonary Embolism and Atrial Fibrillation, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (time frame: after 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586287, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.