Clinical trial NCT00262275: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2005-12-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Eric Lim, MB ChB, MSc, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.