Coronary Artery DiseasePhase 4NCT00439855
Enoxaparin Versus Unfractionated Heparin in PCI
A Phase 4 study testing Enoxaparin i.v. and unfractionated heparin in people with Coronary Artery Disease, run by Triemli Hospital at 1 site in Switzerland.
Trial summary
Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Enoxaparin i.v. and unfractionated heparin
- Type of treatment
- Injection or infusion
- How many people
- 2,100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2003to Feb 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PCI for stable ischemia or ACS
Who cannot join
- Cardiogenic shock,
- Pretreatment with study drugs,
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Cardiology Triemli Hospital Zurich
Zurich, 8063
About this study
Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI
- Conditions
- Coronary Artery Disease
- Being tested
- Enoxaparin i.v., unfractionated heparin
- Keywords
- Enoxaparin, heparin, hemorrhages
- Medical subject headings
- Coronary Artery Disease, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin i.v.Drug
unfractionated heparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadruple endpoint: death, MI, urgent TVR, major bleeding
Secondary outcomes (1)
major bleeding, minor bleeding, thrombocytopenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startSep 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 2,100 participants
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Investigators
- osmund bertel, MD, Principal investigator, Division of Cardiology Triemli Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439855
- Sponsor's protocol ID
- ZEUS
- Status last verified
- Feb 2007
- First submitted
- 23 Feb 2007
- Last updated
- 26 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enoxaparin Versus Unfractionated Heparin in PCI
- ClinicalTrials.gov ID
- NCT00439855
- Acronym / sponsor ID
- ZEUS
- Conditions
- Coronary Artery Disease
- Keywords
- Enoxaparin, heparin, hemorrhages
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,100 participants
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Feb 2006
- First posted
- 26 Feb 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.
Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PCI for stable ischemia or ACS
Key exclusion criteria (3 listed)
- Cardiogenic shock,
- Pretreatment with study drugs,
- Lack of informed consent
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 |
|---|---|---|
| Enoxaparin i.v. | Drug | – |
| unfractionated heparin | Drug | – |
Primary outcome
Quadruple endpoint: death, MI, urgent TVR, major bleeding
1 secondary outcome
major bleeding, minor bleeding, thrombocytopenia
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 26 Feb 2007.
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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.
osmund bertel, MD principal investigator
Division of Cardiology Triemli Hospital Zurich
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 Enoxaparin i.v. and unfractionated heparin in people with Coronary Artery Disease, run by Triemli Hospital 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 3 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 26 Feb 2007. 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?
Quadruple endpoint: death, MI, urgent TVR, major bleeding. 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 26 Feb 2007.