Optimum Platelet Inhibition After Coronary Bypass Surgery

Ischemic Heart Disease Clinical Trial

Official title:

Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262275
• Other study ID #: LREC 01/624
• Status: Completed
• Phase: N/A
• First received: December 5, 2005
• Last updated: January 21, 2016
• Start date: July 2002

Study information

• Verified date: January 2016
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin, Clopidogrel

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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;4:1 — View 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; — View Citation