Acute Pulmonary EmbolismPhase 4NCT00711308
Tinzaparin in the Treatment of the Acute Pulmonary Embolism
A Phase 4 study testing tinzaparin and acenocoumarol in people with Acute Pulmonary Embolism, run by Complejo Hospitalario Xeral-Calde at 4 sites in Spain.
Trial summary
The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- 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
- 102 participants
- Where
- 4 sitesSpain
- Study dates
- Apr 2005to Feb 2009
- 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
- Symptomatic pulmonary embolism patients confirmed by:
- High probability ventilation/perfusion lung scan according to the PIOPED criteria
- Spiral chest computed tomography, or
- Pulmonary arteriography
- Aged 18 years or above, of either sex
- The patient must provide signed informed consent
- Patients will be agreed for receiving ambulatory anticoagulant treatment
Who cannot join
- Massive pulmonary embolism
- Allergy to heparin, other components of Tinzaparin or acenocoumarol
- Previous thrombocytopenia induced by heparin
- Thrombocytopenia < 100000/mm3
- History/signs/symptoms of congenital bleeding disorder
- Life expectancy less than 90 days
Show all 12Show fewer
- Unfractioned heparin anticoagulation for more than 36 hours prior enrollment
- Inability to participate in the home tinzaparin program
- Clinical overt gastrointestinal blood loss due to peptic ulcer, intestinal tumours, oesophagitis or diverticulosis
- Hemoglobin lower than 7 g/dL or Creatinin > 3mg/dL
- Cerebral-vascular accident
- Cerebral, medullary and ophthalmological surgery
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Pneumology Service
Lugo, Lugo, 27004
Pneumology Service. Hospital Clínico
Santiago de Compostela, A Coruña, 15706
Pneumology Service. Hospital Xeral Cies
Vigo, Pontevedra, 36204
Pneumology Service. Hospital do Meixoeiro
Vigo, Pontevedra, 36214
About this study
Official title: Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism
The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.
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 6 months in patients with acute venous thrombosis.
To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- tinzaparin, acenocoumarol
- Keywords
- pulmonary embolism, low molecular weight heparin, vitamin K antagonist, Longterm
- Medical subject headings
- Pulmonary Embolism
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 antagonist
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 followed by acenocoumarol for 6 months Receives: Drug: tinzaparin; Drug: acenocoumarol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
Measured: 6 months
Secondary outcomes (2)
direct and indirect cost of each treatment regimen
Measured: 6 months
Major haemorrhagic events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startApr 2005
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Xeral-Calde
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Investigators
- Luis Pérez de Llano, MD, Study chair, Complejo Hospitalario Xeral Calde (Lugo)Alejandro Veres Racamonde, MD, Principal investigator, Complejo Hospitalario Xeral Calde (Lugo)Manuel Núnez Delgado, MD, Principal investigator, Hospital do Meixoeiro (Vigo)Ana Palacios Bartolomé, MD, Principal investigator, Hospital Clínico de SantiagoVirginia Leiro Fernández, MD, Principal investigator, Hospital Xeral (Vigo)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711308
- Sponsor's protocol ID
- EX0401ES
- Other IDs
- eudract-no. 2004-002019-97
- Status last verified
- Feb 2009
- First submitted
- 3 Jul 2008
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT00711308
- Acronym / sponsor ID
- EX0401ES
- Conditions
- Acute Pulmonary Embolism
- Keywords
- pulmonary embolism, low molecular weight heparin, vitamin K antagonist, Longterm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Complejo Hospitalario Xeral-CaldeUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Apr 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Jul 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 the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.
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 6 months in patients with acute venous thrombosis.
To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.
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: tinzaparin, Drug: acenocoumaroltinzaparin 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 (7 listed)
- Symptomatic pulmonary embolism patients confirmed by:
- Aged 18 years or above, of either sex
- The patient must provide signed informed consent
- Patients will be agreed for receiving ambulatory anticoagulant treatment
Key exclusion criteria (12 listed)
- Massive pulmonary embolism
- Allergy to heparin, other components of Tinzaparin or acenocoumarol
- Previous thrombocytopenia induced by heparin
- Thrombocytopenia < 100000/mm3
- History/signs/symptoms of congenital bleeding disorder
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 | acenocoumarol, tinzaparin |
| acenocoumarolAlso: vitamin K antagonistacenocoumarol for 6 months | Drug | acenocoumarol |
Primary outcome
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
Time frame: 6 months
2 secondary outcomes
direct and indirect cost of each treatment regimen
Time frame: 6 months
Major haemorrhagic events
Time frame: 6 months
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 13 Feb 2009.
Related trials for Acute Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
Pulmonary Embolism
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
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.
Luis Pérez de Llano, MD study chair
Complejo Hospitalario Xeral Calde (Lugo)
Alejandro Veres Racamonde, MD principal investigator
Complejo Hospitalario Xeral Calde (Lugo)
Manuel Núnez Delgado, MD principal investigator
Hospital do Meixoeiro (Vigo)
4 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 Acute Pulmonary Embolism, run by Complejo Hospitalario Xeral-Calde at 4 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 7 inclusion and 12 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 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin (time frame: 6 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 13 Feb 2009.