Ischemic Heart DiseaseNCT00260377
Aspirin Resistance Following Coronary Bypass Surgery
A study testing Coronary artery bypass surgery in people with Ischemic Heart Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Coronary artery bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to Dec 2006
- Phase
- Interventional
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing Coronary artery bypass surgery
- Patients who signed Informed Consent Form
Who cannot join
- Concomitant valve surgery or carotid surgery or off-pump surgery
- Need for anticoagulation therapy for any reason
- Another antiplatelet medications at least 7 days prior to surgery
- Contra-indication for aspirin treatment
- Thrombocytopenia / thrombocytopathia
- NSAIDs treatment for chronic medical conditions
- Reluctance to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.
- Conditions
- Ischemic Heart Disease
- Being tested
- Coronary artery bypass surgery
- Keywords
- Aspirin treatment, Aspirin resistance, Coronary bypass surgery
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation
Inotropic support
Mortality
Perioperative MI
Perioperative stroke
Bleeding / reopen / transfusion
Dysrhythmias
Secondary outcomes (4)
ICU stay
In-hospital stay
Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias
Need for repeat revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2006
- Study completionDec 2006
Why it stopped: The researcher had left the hospital and the project was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Jacob Lavee, Dr, Principal investigator, jacob.lavee@sheba.health.gov.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260377
- Sponsor's protocol ID
- SHEBA-03-3107-JL-CTIL
- Status last verified
- Sep 2008
- First submitted
- 29 Nov 2005
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Resistance Following Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00260377
- Acronym / sponsor ID
- SHEBA-03-3107-JL-CTIL
- Conditions
- Ischemic Heart Disease
- Keywords
- Aspirin treatment, Aspirin resistance, Coronary bypass surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The researcher had left the hospital and the project was stopped
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2005
- Primary completion
- Jun 2006
- Study completion
- Dec 2006
- First posted
- 1 Dec 2005 (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.
Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing Coronary artery bypass surgery
- Patients who signed Informed Consent Form
Key exclusion criteria (7 listed)
- Concomitant valve surgery or carotid surgery or off-pump surgery
- Need for anticoagulation therapy for any reason
- Another antiplatelet medications at least 7 days prior to surgery
- Contra-indication for aspirin treatment
- Thrombocytopenia / thrombocytopathia
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 |
|---|---|---|
| Coronary artery bypass surgery | Procedure or surgery | – |
Primary outcome
Ventilation
Inotropic support
Mortality
Perioperative MI
Perioperative stroke
Bleeding / reopen / transfusion
Dysrhythmias
4 secondary outcomes
ICU stay
In-hospital stay
Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias
Need for repeat revascularization
Results and safety
The study was stopped early (reason given: The researcher had left the hospital and the project was stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
Jacob Lavee, Dr principal investigator
jacob.lavee@sheba.health.gov.il
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery bypass surgery in people with Ischemic Heart Disease, run by Sheba Medical Center 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Sep 2008. 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?
The study was stopped early (reason given: The researcher had left the hospital and the project was stopped). Results are not available in the source record.
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?
Ventilation. The study lists 7 primary outcomes in all. 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 9 Sep 2008.