Optimum Platelet Inhibition After Coronary Bypass Surgery | NCT00262275

Studies
Optimum Platelet Inhibition After Coronary Bypass Surgery

NCT00262275

Sponsor

Papworth Hospital NHS Foundation Trust

Status

Completed

Last Update Posted

Jan 22, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Ischemic Heart Disease

Interventions

Aspirin, Clopidogrel

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Jul 2004Actual

Completion Date

Not provided

First Submitted Date

Dec 5, 2005

First Submission Date that Met QC Criteria

Dec 5, 2005

First Posted Date

Dec 6, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2016

Last Update Posted Date

Jan 22, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Aspirin, Clopidogrel	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Eric Lim, MB ChB, MSc, MRCS	Papworth Hospital NHS Foundation Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Papworth Hospital		Cambridge		CB3 8RE	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15354104	Result	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.
16716214	Result

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

ID	Term
D001241	Aspirin
D000077144	Clopidogrel