Deep Venous ThrombosisPhase 3DDOAT2006NCT00895505
D-Dimer Guided Oral Anticoagulant Treatment (OAT)
A Phase 3 study testing Phenprocoumon and Warfarin-Natrium in people with Deep Venous Thrombosis, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Phenprocoumon and Warfarin-Natrium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Feb 2012
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be enrolled in this study, patients must:
- have an objectively confirmed first episode of unprovoked VTE or of VTE during a minor transient risk factor. Minor transient risk factors include 6 weeks of estrogen therapy, prolonged air travel (i.e., > 6 hours), pregnancy, less marked leg injuries or immobilization without injury or surgical intervention
- be scheduled to receive oral anticoagulant treatment for at least 3 months
- be willing to be randomized
- be willing to participate for the full duration of the study
Who cannot join
- pregnancy or breast feeding
- contraindications against OAT (i.e., intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
- age < 18 years
- presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i.e., antithrombin deficiency, hereditary PC deficiency)
- poor patient compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53105
Bernd Poetzsch, Professor, bernd.poetzsch@ukb.uni-bonn.de
Bernd Poetzsch, Professor
About this study
Official title: Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial
This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design.
Read the detailed description
After a first episode of acute deep venous thrombosis (DVT) the risk of recurrence is relatively high and clinical consequences are important. Therefore, secondary prophylaxis using oral anticoagulant treatment (OAT) is usually established in these patients. This treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. Major bleeding complications can be expected in ~2% patient-years. Therefore, current recommendations limit OAT to a period of 3 to 12 months. After stopping of OAT, however, ~10 % of patients with an initial episode of unprovoked DVT will develop a recurrent event within 1 year. This group of patients may benefit from prolonged OAT. The results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of D-Dimer after withdrawal of OAT. D-Dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. Based on these data we hypothesize that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of DVT. This clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Phenprocoumon, Warfarin-Natrium
- Keywords
- DVT, Venous thromboembolism, D-Dimer, thrombophilia, secondary prophylaxis, secondary prophylaxis using oral anticoagulant treatment (OAT), higher risk of recurrence in patients showing increased levels, of D-Dimer after withdrawal of OAT, D-Dimer-based treatment
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenprocoumonDrug
Phenprocoumon 3 mg, tablet, INR adjusted
Warfarin-NatriumDrug
Warfarin-Natrium 5 mg, tablet, INR adjusted
| Study group | Role | What they receive |
|---|---|---|
| oral anticoagulants | Active comparator | Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis. Receives: Drug: Phenprocoumon; Drug: Warfarin-Natrium |
| 2 | No intervention | Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Measured: Duration of intervention per patient (24 months)
Secondary outcomes (1)
Incidence and severity of signs and symptoms associated with OAT-induced bleeding measured using the World Health Organization (WHO) bleeding scale.
Measured: Duration of intervention per patient (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startFeb 2008
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, German Federal Ministry of Education and Research
- Investigators
- Bernd Poetzsch, Professor, Principal investigator, Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895505
- Sponsor's protocol ID
- DDOAT2006
- Acronym
- DDOAT2006
- Status last verified
- May 2009
- First submitted
- 7 May 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial
- ClinicalTrials.gov ID
- NCT00895505
- Acronym / sponsor ID
- DDOAT2006 / DDOAT2006
- Conditions
- Deep Venous Thrombosis
- Keywords
- DVT, Venous thromboembolism, D-Dimer, thrombophilia, secondary prophylaxis, secondary prophylaxis using oral anticoagulant treatment (OAT), higher risk of recurrence in patients showing increased levels, of D-Dimer after withdrawal of OAT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- German Research Foundation, German Federal Ministry of Education and Research
- Study start
- Feb 2008
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 8 May 2009 (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.
This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design.
Detailed description
After a first episode of acute deep venous thrombosis (DVT) the risk of recurrence is relatively high and clinical consequences are important. Therefore, secondary prophylaxis using oral anticoagulant treatment (OAT) is usually established in these patients. This treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. Major bleeding complications can be expected in ~2% patient-years. Therefore, current recommendations limit OAT to a period of 3 to 12 months. After stopping of OAT, however, ~10 % of patients with an initial episode of unprovoked DVT will develop a recurrent event within 1 year. This group of patients may benefit from prolonged OAT. The results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of D-Dimer after withdrawal of OAT. D-Dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. Based on these data we hypothesize that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of DVT. This clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral anticoagulants | Active comparator | Drug: Phenprocoumon, Drug: Warfarin-NatriumExperimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis. |
| 2 | No intervention | –Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have an objectively confirmed first episode of unprovoked VTE or of VTE during a minor transient risk factor. Minor transient risk factors include 6 weeks of estrogen therapy, prolonged air travel (i.e., > 6 hours), pregnancy, less marked leg injuries or immobilization without injury or surgical intervention
- be scheduled to receive oral anticoagulant treatment for at least 3 months
- be willing to be randomized
- be willing to participate for the full duration of the study
Key exclusion criteria (5 listed)
- pregnancy or breast feeding
- contraindications against OAT (i.e., intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
- age < 18 years
- presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i.e., antithrombin deficiency, hereditary PC deficiency)
- poor patient compliance
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 |
|---|---|---|
| PhenprocoumonPhenprocoumon 3 mg, tablet, INR adjusted | Drug | oral anticoagulants |
| Warfarin-NatriumWarfarin-Natrium 5 mg, tablet, INR adjusted | Drug | oral anticoagulants |
Primary outcome
Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Time frame: Duration of intervention per patient (24 months)
1 secondary outcome
Incidence and severity of signs and symptoms associated with OAT-induced bleeding measured using the World Health Organization (WHO) bleeding scale.
Time frame: Duration of intervention per patient (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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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.
Bernd Poetzsch, Professor principal investigator
Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenprocoumon and Warfarin-Natrium in people with Deep Venous Thrombosis, run by University Hospital, Bonn at 1 site in Germany.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 May 2009. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernd Poetzsch, Professor (+49-228-28716745, bernd.poetzsch@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE) (time frame: Duration of intervention per patient (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2009.