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Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery

NCT01358422 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 830

Last updated 2015-10-14

No results posted yet for this study

Summary

Research questions:

1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE) associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?
2. What is the absolute risk increase for clinically significant bleeding during the same period associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?

In brief the design of the study is as follows:

* We will study patients undergoing non-cardiac surgery within four years of coronary stenting.
* We will record the anti-platelet agents taken by patients before, during and after surgery.
* We will record cardiac and bleeding events that occur whilst the patient is in hospital.
* We will use the statistical technique of propensity scoring to match patients who have similar risk factors and who received different anti-platelet regimens.
* We will compare the incidence of cardiac events and bleeding in the matched groups.

Conditions

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • European Society of Anaesthesiology

    lead OTHER

Principal Investigators

  • Simon Howell, MD · Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358422 on ClinicalTrials.gov