Coronary Artery DiseasePhase 3NCT01268917
The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass
A Phase 3 study testing aspirin in people with Coronary Artery Disease and Off-pump Coronary Artery Bypass, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Off-pump Coronary Artery Bypass, Aspirin
- What is being tested?
- aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Mar 2011
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
- patient able to give informed consent
Who cannot join
- on-pump CABG
- combined with the valve surgery
- Preoperative use of clopidogrel and warfarin
- allergy to aspirin
- History of severe liver disease
- History of bleeding diathesis,significant GI bleed
- Patient has known renal failure or contraindication for Cardiac CT Angio
- Redo CABG
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, 100037
Hengchao Wu, MD, 8601088398701, whcwuhengchao@163.com
Hansong Sun, MD
About this study
Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.
- Being tested
- aspirin
- Keywords
- coronary artery disease, off-pump coronary artery bypass, aspirin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
aspirin 100mg daily until the surgery day
aspirinDrug
aspirin is stopped 5-7 days before operation
| Study group | Role | What they receive |
|---|---|---|
| preoperative aspirin use | Experimental | Not described Receives: Drug: aspirin |
| preoperative aspirin nonuse | No intervention | Not described Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft patency examined by CT scan
we would like to compare the graft patency within the one week after the surgery between the preoperative aspirin use and preoperative nonuse.We just want to know wether preoperative aspirin use could improve the graft patency in off-pump coronary artery bypass.
Measured: one week after surgery
Secondary outcomes (1)
Bleeding, transfusion, re-exploration
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268917
- Sponsor's protocol ID
- Fuwai Hospital 2010-259
- Status last verified
- Mar 2010
- First submitted
- 29 Dec 2010
- Last updated
- 31 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen S, Wu H, Yang T, Li B, Hu Y, Sun H. Does Early Graft Patency Benefit from Perioperative Statin Therapy? A Propensity Score-Matched Study of Patients Undergoing Off-Pump Coronary Artery Bypass Surgery. Cardiovasc Ther. 2019 Aug 6;2019:1582183. doi: 10.1155/2019/1582183. eCollection 2019.
PubMed 31772605
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT01268917
- Acronym / sponsor ID
- Fuwai Hospital 2010-259
- Keywords
- coronary artery disease, off-pump coronary artery bypass, aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- First posted
- 31 Dec 2010 (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.
Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative aspirin use | Experimental | Drug: aspirin |
| preoperative aspirin nonuse | No intervention | Drug: aspirin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
- patient able to give informed consent
Key exclusion criteria (8 listed)
- on-pump CABG
- combined with the valve surgery
- Preoperative use of clopidogrel and warfarin
- allergy to aspirin
- History of severe liver disease
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 |
|---|---|---|
| aspirinaspirin 100mg daily until the surgery day | Drug | preoperative aspirin use |
| aspirinaspirin is stopped 5-7 days before operation | Drug | preoperative aspirin nonuse |
Primary outcome
graft patency examined by CT scan
Time frame: one week after surgery
we would like to compare the graft patency within the one week after the surgery between the preoperative aspirin use and preoperative nonuse.We just want to know wether preoperative aspirin use could improve the graft patency in off-pump coronary artery bypass.
1 secondary outcome
Bleeding, transfusion, re-exploration
Time frame: perioperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
- Derived from this study: PubMed 31772605Chen S, Wu H, Yang T, Li B, Hu Y, Sun H. Does Early Graft Patency Benefit from Perioperative Statin Therapy? A Propensity Score-Matched Study of Patients Undergoing Off-Pump Coronary Artery Bypass Surgery. Cardiovasc Ther. 2019 Aug 6;2019:1582183. doi: 10.1155/2019/1582183. eCollection 2019.
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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.
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 aspirin in people with Coronary Artery Disease and Off-pump Coronary Artery Bypass, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 8 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 31 Dec 2010. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft patency examined by CT scan (time frame: one week after surgery). 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 NCT01268917, which also lists 1 linked publication.
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 31 Dec 2010.