Ischemic Heart DiseaseNCT00262275
Optimum Platelet Inhibition After Coronary Bypass Surgery
A study testing Aspirin, Clopidogrel in people with Ischemic Heart Disease, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Aspirin, Clopidogrel
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2002to Jul 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent.
Who cannot join
- Preoperative exclusion criteria:
- patients who are have not stopped aspirin 7 days prior to surgery
- patients on concomitant NSAIDS
- patients with a previous history platelet disorders, splenectomy or haematological disorders
- patients with aspirin induced asthma
- patients with any contraindications to aspirin (GI bleed)
Show all 18Show fewer
- patients who are on any medication that may result in a serious drug interaction with aspirin (warfarin)
- Women of childbearing potential
- Patients of less than 18 years
- If informed consent cannot be obtained
- If for any reason the consultant surgeon or anaesthetist deems it to be appropriate
- Operative exclusion criteria:
- Concomitant procedures
- Postoperative exclusion criteria:
- patients who receive platelet transfusion
- patients who receive NSAIDS
- requirement for intra aortic balloon pump support
- failure of extubation within 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel
To investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery.
- Conditions
- Ischemic Heart Disease
- Being tested
- Aspirin, Clopidogrel
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin, ClopidogrelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startJul 2002
- Primary completionJul 2004
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 Ischemic Heart 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eric Lim, MB ChB, MSc, MRCS, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262275
- Sponsor's protocol ID
- LREC 01/624
- Status last verified
- Jan 2016
- First submitted
- 5 Dec 2005
- Last updated
- 22 Jan 2016
- Results posted
- No
Publications
Lim E, Cornelissen J, Routledge T, Kirtland S, Charman SC, Bellm S, Munday H, Khan O, Masood I, Large S. Clopidogrel did not inhibit platelet function early after coronary bypass surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2004 Sep;128(3):432-5. doi: 10.1016/j.jtcvs.2004.03.007.
PubMed 15354104Lim E, Cornelissen J, Routledge T, Ali A, Kirtland S, Sharples L, Sheridan K, Bellm S, Munday H, Large S. Biological efficacy of low versus medium dose aspirin after coronary surgery: results from a randomized trial [NCT00262275]. BMC Med. 2006 May 22;4:12. doi: 10.1186/1741-7015-4-12.
PubMed 16716214Lim E, Carballo S, Cornelissen J, Ali ZA, Grignani R, Bellm S, Large S. Dose-related efficacy of aspirin after coronary surgery in patients With Pl(A2) polymorphism (NCT00262275). Ann Thorac Surg. 2007 Jan;83(1):134-8. doi: 10.1016/j.athoracsur.2006.08.002.
PubMed 17184645
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel
- ClinicalTrials.gov ID
- NCT00262275
- Acronym / sponsor ID
- LREC 01/624
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Jul 2002
- Primary completion
- Jul 2004 (actual)
- First posted
- 6 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.
To investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent.
Key exclusion criteria (18 listed)
- patients who are have not stopped aspirin 7 days prior to surgery
- patients on concomitant NSAIDS
- patients with a previous history platelet disorders, splenectomy or haematological disorders
- patients with aspirin induced asthma
- patients with any contraindications to aspirin (GI bleed)
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 |
|---|---|---|
| Aspirin, Clopidogrel | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Jan 2016.
- Results publication: PubMed 15354104Lim E, Cornelissen J, Routledge T, Kirtland S, Charman SC, Bellm S, Munday H, Khan O, Masood I, Large S. Clopidogrel did not inhibit platelet function early after coronary bypass surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2004 Sep;128(3):432-5. doi: 10.1016/j.jtcvs.2004.03.007.
- Results publication: PubMed 16716214Lim E, Cornelissen J, Routledge T, Ali A, Kirtland S, Sharples L, Sheridan K, Bellm S, Munday H, Large S. Biological efficacy of low versus medium dose aspirin after coronary surgery: results from a randomized trial [NCT00262275]. BMC Med. 2006 May 22;4:12. doi: 10.1186/1741-7015-4-12.
- Derived from this study: PubMed 17184645Lim E, Carballo S, Cornelissen J, Ali ZA, Grignani R, Bellm S, Large S. Dose-related efficacy of aspirin after coronary surgery in patients With Pl(A2) polymorphism (NCT00262275). Ann Thorac Surg. 2007 Jan;83(1):134-8. doi: 10.1016/j.athoracsur.2006.08.002.
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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.
Eric Lim, MB ChB, MSc, MRCS principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Clopidogrel in people with Ischemic Heart Disease, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 18 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 22 Jan 2016. 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 United Kingdom. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00262275, 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 22 Jan 2016.