Acute Coronary SyndromeNCT00354796
The Effect of Reduced Dose of Enoxaparin on the Outcomes of Treatment With Enoxaparin
An observational study of Acute Coronary Syndrome and Venous Thromboembolism, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Venous Thromboembolism, Atrial Fibrillation
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2006to Oct 2015
- Phase
- Observational
- 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
Study population: patients admitted to tertiary hospital
Who may be able to join
- treatment with enoxaparin
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: The Effect of Reduced Dose of Enoxaparin on the Laboratory and Clinical Outcomes of Treatment With Enoxaparin
We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy.
Read the detailed description
Patients treated with enoxaparin will be followed, sociodemographic , clinical and laboratory data will be collected. Clinical efficacy as well as adverse events will be monitored.
- Keywords
- bleeding, anticoagulation, LMWH, Enoxaparin
- Medical subject headings
- Acute Coronary Syndrome, Venous Thromboembolism, Atrial Fibrillation, Thrombophilia, Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJul 2006
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Mordechai Muszkat, MD, Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354796
- Sponsor's protocol ID
- enoxap-HMO-CTIL
- Status last verified
- Jun 2011
- First submitted
- 19 Jul 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reduced Dose of Enoxaparin on the Laboratory and Clinical Outcomes of Treatment With Enoxaparin
- ClinicalTrials.gov ID
- NCT00354796
- Acronym / sponsor ID
- enoxap-HMO-CTIL
- Keywords
- bleeding, anticoagulation, LMWH, Enoxaparin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Oct 2015 (estimated)
- First posted
- 20 Jul 2006 (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.
We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy.
Detailed description
Patients treated with enoxaparin will be followed, sociodemographic , clinical and laboratory data will be collected. Clinical efficacy as well as adverse events will be monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to tertiary hospital
Key inclusion criteria (1 listed)
- treatment with enoxaparin
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
Mordechai Muszkat, MD principal investigator
Hadassah University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Venous Thromboembolism, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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 6 Jul 2011. 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 Israel. 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.
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 Mordechai Muszkat, MD (00-972-2-6776449, muszkatm@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 6 Jul 2011.