Optimum Platelet Inhibition After Coronary Bypass Surgery

NCT ID: NCT00262275

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aspirin, Clopidogrel

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Lim, MB ChB, MSc, MRCS

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Foundation Trust

Locations

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Papworth Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 15354104 (View on PubMed)

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.

Reference Type RESULT
PMID: 16716214 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17184645 (View on PubMed)

Other Identifiers

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LREC 01/624

Identifier Type: -

Identifier Source: org_study_id

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