Monitoring Response to Antiplatelet Therapy

Sponsor
NHS Greater Glasgow and Clyde (Other)
Overall Status
Unknown status
CT.gov ID
NCT00327041
Collaborator
(none)
40
1
8
5

Study Details

Study Description

Brief Summary

Antiplatelet therapy plays a key role in the prevention of complications related to coronary angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and clopidogrel are now universally prescribed in patients undergoing these procedures. However, loading and maintenance doses have not been established and variation in individual response is emerging. New tests to assess the effects of these drugs are being developed but have yet to be incorporated into routine clinical practice. We will assess the effects of aspirin and clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which can be carried out at the bedside. We will compare the results with alternative laboratory based tests and look for an association between the results, peri-procedural myocardial necrosis and subsequent cardiovascular events.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Official Title:
    Pilot Study Investigating the Use of a Variety of Assays to Detect Individual Response to Antiplatelet Therapy
    Study Start Date :
    Jan 1, 2006
    Study Completion Date :
    Sep 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      Patients aged 18-80 undergoing intended PCI for conventional indications. Informed written consent.

      Exclusion Criteria:

      Administration of GPIIbIIIa therapy prior to PCI, Oral anticoagulation, ticlopidine, dipyridamole, NSAID therapy, Pregnancy, Troponin I >0.2mcg/l on day of procedure, Chest pain in the 24 hrs prior to PCI. Anaemia (Hb<10g/dl). Platelet Count <150 or >450 x10^9/l, Personal or family history of bleeding disorder.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Western Infirmary Glasgow Scotland United Kingdom G11 6NT

      Sponsors and Collaborators

      • NHS Greater Glasgow and Clyde

      Investigators

      • Principal Investigator: Keith G Oldroyd, MBChB, MD, FRCP, NHS Greater Glasgow and Clyde

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00327041
      Other Study ID Numbers:
      • rgoodtrial001
      First Posted:
      May 17, 2006
      Last Update Posted:
      May 17, 2006
      Last Verified:
      May 1, 2006

      Study Results

      No Results Posted as of May 17, 2006