ThromboembolismPhase 3NCT00451412
A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients
A Phase 3 study testing Certoparin and Unfractionated Heparin in people with Thromboembolism, run by Novartis at 1 site in Germany.
Trial summary
This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Thromboembolism
- What is being tested?
- Certoparin and Unfractionated Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,254 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Jun 2009
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized medical patients 70 years of age or older
- Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
- written informed consent
Who cannot join
- immobilization longer than 3 days prior to randomization
- prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
- expected major surgical or invasive procedure within the next 3 weeks after randomization
- LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
- immobilization due to cast or fracture
- indication for anticoagulatory or thrombolytic therapy
Show all 10Show fewer
- acute symptomatic DVT / PE
- known hypersensitivity to any of the study drugs or drugs with similar chemical structures
- Acute or history of heparin induced thrombocytopenia type II (HIT II)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients
This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.
- Conditions
- Thromboembolism
- Being tested
- Certoparin, Unfractionated Heparin
- Keywords
- Venous thromboembolism, Medical patients, Heparin, Low molecular weight heparin, Deep vein thrombosis, Certoparin, Embolism and Thrombosis
- Medical subject headings
- Thromboembolism, Venous Thromboembolism, Venous Thrombosis, Embolism and Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CertoparinDrug
Also called Sandoparin, Embolex, low molecular weight heparin
3000 U anti XA of certoparin in 0.3 ml solution, once daily
Unfractionated HeparinDrug
solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Certoparin | Experimental | Not described Receives: Drug: Certoparin |
| Unfractionated Heparin | Active comparator | Not described Receives: Drug: Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
Measured: 20 days
Secondary outcomes (5)
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,
Measured: 20 days
symptomatic DVT,
Measured: 20 days
symptomatic non-fatal pulmonary embolism (PE),
Measured: 20 days
combination of proximal DVT, non fatal PE and death from all causes including PE
Measured: 20 days
VTE related death,
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451412
- Sponsor's protocol ID
- CMEX839BDE03
- Status last verified
- Jul 2012
- First submitted
- 21 Mar 2007
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Haas S, Schellong SM, Tebbe U, Gerlach HE, Bauersachs R, Melzer N, Abletshauser C, Sieder C, Bramlage P, Riess H. Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY. BMC Cancer. 2011 Jul 26;11:316. doi: 10.1186/1471-2407-11-316.
PubMed 21791091Bauersachs R, Schellong SM, Haas S, Tebbe U, Gerlach HE, Abletshauser C, Sieder C, Melzer N, Bramlage P, Riess H. CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal insufficiency. Thromb Haemost. 2011 Jun;105(6):981-8. doi: 10.1160/TH10-09-0614. Epub 2011 Apr 20.
PubMed 21505722Tebbe U, Schellong SM, Haas S, Gerlach HE, Abletshauser C, Sieder C, Bramlage P, Riess H. Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study. Am Heart J. 2011 Feb;161(2):322-8. doi: 10.1016/j.ahj.2010.10.005.
PubMed 21315215
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients
- ClinicalTrials.gov ID
- NCT00451412
- Acronym / sponsor ID
- CMEX839BDE03
- Conditions
- Thromboembolism
- Keywords
- Venous thromboembolism, Medical patients, Heparin, Low molecular weight heparin, Deep vein thrombosis, Certoparin, Embolism and Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,254 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Mar 2007 (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 study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certoparin | Experimental | Drug: Certoparin |
| Unfractionated Heparin | Active comparator | Drug: Unfractionated Heparin |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hospitalized medical patients 70 years of age or older
- Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
- written informed consent
Key exclusion criteria (10 listed)
- immobilization longer than 3 days prior to randomization
- prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
- expected major surgical or invasive procedure within the next 3 weeks after randomization
- LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
- immobilization due to cast or fracture
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 |
|---|---|---|
| CertoparinAlso: Sandoparin, Embolex, low molecular weight heparin3000 U anti XA of certoparin in 0.3 ml solution, once daily | Drug | Certoparin |
| Unfractionated Heparinsolution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily | Drug | Unfractionated Heparin |
Primary outcome
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
Time frame: 20 days
5 secondary outcomes
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,
Time frame: 20 days
symptomatic DVT,
Time frame: 20 days
symptomatic non-fatal pulmonary embolism (PE),
Time frame: 20 days
combination of proximal DVT, non fatal PE and death from all causes including PE
Time frame: 20 days
VTE related death,
Time frame: 20 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 25 Jul 2012.
- Derived from this study: PubMed 21791091Haas S, Schellong SM, Tebbe U, Gerlach HE, Bauersachs R, Melzer N, Abletshauser C, Sieder C, Bramlage P, Riess H. Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY. BMC Cancer. 2011 Jul 26;11:316. doi: 10.1186/1471-2407-11-316.
- Derived from this study: PubMed 21505722Bauersachs R, Schellong SM, Haas S, Tebbe U, Gerlach HE, Abletshauser C, Sieder C, Melzer N, Bramlage P, Riess H. CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal insufficiency. Thromb Haemost. 2011 Jun;105(6):981-8. doi: 10.1160/TH10-09-0614. Epub 2011 Apr 20.
- Derived from this study: PubMed 21315215Tebbe U, Schellong SM, Haas S, Gerlach HE, Abletshauser C, Sieder C, Bramlage P, Riess H. Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study. Am Heart J. 2011 Feb;161(2):322-8. doi: 10.1016/j.ahj.2010.10.005.
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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.
Novartis study director
Novartis
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 Certoparin and Unfractionated Heparin in people with Thromboembolism, run by Novartis 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 3 inclusion and 10 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 25 Jul 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 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?
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 venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (time frame: 20 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 NCT00451412, which also lists 3 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 25 Jul 2012.