Optimum Platelet Inhibition After Coronary Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
Papworth Hospital
ClinicalTrials.gov Identifier:
NCT00262275
First received: December 5, 2005
Last updated: July 20, 2006
Last verified: March 2001
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Drug: Aspirin, Clopidogrel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel

Resource links provided by NLM:


Further study details as provided by Papworth Hospital:

Study Start Date: July 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00262275

Locations
United Kingdom
Papworth Hospital
Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Papworth Hospital
Investigators
Principal Investigator: Eric Lim, MB ChB, MSc, MRCS Papworth Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00262275     History of Changes
Other Study ID Numbers: LREC 01/624
Study First Received: December 5, 2005
Last Updated: July 20, 2006
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014