Back to resultsOptimum Platelet Inhibition After Coronary Bypass Surgery
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aspirin, Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria: We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent. Exclusion Criteria: 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) 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
Sites / Locations
- Papworth Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00262275
First Posted
December 5, 2005
Last Updated
January 21, 2016
Sponsor
Papworth Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00262275
Brief Title
Optimum Platelet Inhibition After Coronary Bypass Surgery
Official Title
Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aspirin, Clopidogrel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent.
Exclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Lim, MB ChB, MSc, MRCS
Organizational Affiliation
Papworth Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB3 8RE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15354104
Citation
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.
Results Reference
result
PubMed Identifier
16716214
Citation
Lim 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.
Results Reference
result
PubMed Identifier
17184645
Citation
Lim 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.
Results Reference
derived
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Optimum Platelet Inhibition After Coronary Bypass Surgery
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