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Trial record 39 of 1324 for:    ASPIRIN AND Platelet Aggregation

Optimum Platelet Inhibition After Coronary Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00262275
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE December 5, 2005
First Posted Date  ICMJE December 6, 2005
Last Update Posted Date January 22, 2016
Study Start Date  ICMJE July 2002
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00262275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimum Platelet Inhibition After Coronary Bypass Surgery
Official Title  ICMJE Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE Drug: Aspirin, Clopidogrel
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00262275
Other Study ID Numbers  ICMJE LREC 01/624
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Papworth Hospital NHS Foundation Trust
Study Sponsor  ICMJE Papworth Hospital NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Lim, MB ChB, MSc, MRCS Papworth Hospital
PRS Account Papworth Hospital NHS Foundation Trust
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP