Aspirin Responsiveness and Outcome in Coronary Artery Bypass Graft (CABG) Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01174862
First received: August 2, 2010
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

In patients undergoing coronary artery bypass graft (CAGB) surgery, aspirin is commonly prescribed to prevent graft thrombosis and myocardial ischemia. However, there are still a significant number of grafts occluding in the postoperative period. This is partly attributed to reduced aspirin responsiveness, also called "aspirin resistance". At the moment, no standardized definition or laboratory test is available to quantify "aspirin resistance", and strong platelet reactivity in laboratory tests is not necessarily associated with increased thrombotic events. However, there is increasing evidence that reduced aspirin responsiveness in platelet function analyzers is associated with adverse long-term outcome and higher incidence of major adverse events in patients with stable coronary artery disease and in patients undergoing percutaneous coronary intervention. In patients undergoing coronary artery bypass graft surgery, the predictive value of a laboratory finding of reduced aspirin responsiveness remains unclear.

Therefore, the aim of this study is to prospectively evaluate whether the pre- and/or postoperative laboratory finding of reduced aspirin responsiveness defined by MultiplateTM platelet function analyzer is associated with higher incidences of adverse outcome after 30 days and 12 months in patients undergoing CABG surgery.


Condition
Coronary Artery Bypass Graft Triple Vessel
Myocardial Ischemia
Thrombosis
Antithrombotic Drugs [Platelet-aggregation Inhibitors] Causing Adverse Effects in Therapeutic Use

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Cohort Study on the Outcome of Patients With Normal and Reduced Acetylsalicylic Acid Responsiveness Undergoing Coronary Artery Bypass Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Estimated Enrollment: 304
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aspirin responder
Normal aspirin responsiveness in ASPI test (Multiplate)
Aspirin non-responder
Reduced aspirin responsiveness in ASPI test (Multiplate)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing elective CABG surgery (on-pump and off pump surgery)

Criteria

Inclusion criteria:

  • patient undergoing elective CABG surgery
  • therapy with aspirin until at least 2 days before surgery
  • written informed consent

Exclusion criteria:

  • missing written consent
  • no therapy with aspirin or therapy stopped more than 2 days before surgery
  • therapy with clopidogrel more than 3 days before surgery
  • emergency surgery
  • surgery including more than CABG
  • inborn or acquired platelet disorders
  • therapy with Selective Serotonin reuptake inhibitors (SSRI)
  • severe hepatopathy (spontaneous Quick <70%)
  • severe kidney disease (creatinine clearance < 30 ml/min)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01174862

Locations
Switzerland
Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Daniel Bolliger, MD Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland
  More Information

No publications provided

Responsible Party: Daniel Bolliger, PD Dr. med. Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01174862     History of Changes
Other Study ID Numbers: 288/09
Study First Received: August 2, 2010
Last Updated: October 23, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
aspirin
aspirin responsiveness
long-term outcome
CABG

Additional relevant MeSH terms:
Thrombosis
Myocardial Ischemia
Coronary Artery Disease
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
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

ClinicalTrials.gov processed this record on September 30, 2014