Venous ThromboembolismPhase 4NCT00689520
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
A Phase 4 study testing tinzaparin and acenocoumarol in people with Venous Thromboembolism, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
Trial summary
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- tinzaparin and acenocoumarol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2002to Jan 2005
- 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, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
- either sex and over 18 years of age
- referred to the Vascular Surgery Department of the hospital
- onset of symptoms less than 2 weeks
- documented by compression ultrasonography,
Who cannot join
- received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
- pulmonary embolism requiring thrombolytic therapy
- Need of surgical thrombectomy or vena cava interruption
- receiving oral anticoagulant treatment or antiplatelet agents for other conditions
- contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
- platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
Show all 9Show fewer
- severe renal failure necessitating dialysis
- pregnancy
- lumbar puncture within the previous 24 hours
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Vascular surgery service. Hospital Creu Roja de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906
Department of Vascular Surgery. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
Read the detailed description
The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.
- Conditions
- Venous Thromboembolism
- Being tested
- tinzaparin, acenocoumarol
- Keywords
- Venous thromboembolism, low molecular weight heparin, Vitamin K antagonist, Longterm
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tinzaparinDrug
Also called innohep
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
acenocoumarolDrug
Also called Vitamin K antagonists
tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
| Study group | Role | What they receive |
|---|---|---|
| tinzaparin | Experimental | tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months. Receives: Drug: tinzaparin |
| acenocoumarol | Active comparator | tinzaparin for 1 weeks followed by acenocoumarol for 6 months Receives: Drug: acenocoumarol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic recurrent venous thromboembolism
Measured: 12 months
Secondary outcomes (1)
Occurrence of major bleeding
Measured: 6 month treatment interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJan 2002
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Investigators
- Antoni Romera, MD, Study chair, Hospital Universitari de BellvitgeAntoni Romera, MD, Principal investigator, Hospital Universitari de BellvitgeOriol Lapiedra, MD, Principal investigator, Hospital Creu Roja de l'Hospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689520
- Sponsor's protocol ID
- CV1/01
- Other IDs
- CV1/01
- Status last verified
- May 2008
- First submitted
- 28 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT00689520
- Acronym / sponsor ID
- CV1/01
- Conditions
- Venous Thromboembolism
- Keywords
- Venous thromboembolism, low molecular weight heparin, Vitamin K antagonist, Longterm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Jan 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 3 Jun 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.
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
Detailed description
The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tinzaparin | Experimental | Drug: tinzaparintinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months. |
| acenocoumarol | Active comparator | Drug: acenocoumaroltinzaparin for 1 weeks followed by acenocoumarol for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
- either sex and over 18 years of age
- referred to the Vascular Surgery Department of the hospital
- onset of symptoms less than 2 weeks
- documented by compression ultrasonography,
Key exclusion criteria (9 listed)
- received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
- pulmonary embolism requiring thrombolytic therapy
- Need of surgical thrombectomy or vena cava interruption
- receiving oral anticoagulant treatment or antiplatelet agents for other conditions
- contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
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 |
|---|---|---|
| tinzaparinAlso: innoheptinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months | Drug | tinzaparin |
| acenocoumarolAlso: Vitamin K antagoniststinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months | Drug | acenocoumarol |
Primary outcome
Incidence of symptomatic recurrent venous thromboembolism
Time frame: 12 months
1 secondary outcome
Occurrence of major bleeding
Time frame: 6 month treatment interval
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 3 Jun 2008.
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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.
Antoni Romera, MD study chair
Hospital Universitari de Bellvitge
Antoni Romera, MD principal investigator
Hospital Universitari de Bellvitge
Oriol Lapiedra, MD principal investigator
Hospital Creu Roja de l'Hospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tinzaparin and acenocoumarol in people with Venous Thromboembolism, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
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 9 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 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Incidence of symptomatic recurrent venous thromboembolism (time frame: 12 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 3 Jun 2008.