Optimum Platelet Inhibition After Coronary Bypass Surgery

NCT00262275 | Completed

• 1 other identifier: LREC 01/624
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Interventions

Aspirin, Clopidogrel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent.

You may not qualify if:

• 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
• Concomitant procedures
• patients who receive platelet transfusion
• patients who receive NSAIDS
• requirement for intra aortic balloon pump support
• failure of extubation within 24 hours

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital

Cambridge, CB3 8RE, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 15354104 RESULT

• 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.

  PMID: 16716214 RESULT

• 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.

  PMID: 17184645 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eric Lim, MB ChB, MSc, MRCS

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 6, 2005
• Study Start: July 1, 2002
• Primary Completion: July 1, 2004
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

GB (1)