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Monitoring Response to Antiplatelet Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327041
First Posted: May 17, 2006
Last Update Posted: May 17, 2006
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.
Information provided by:
NHS Greater Glasgow and Clyde
  Purpose
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 Phase
Coronary Stenosis Coronary Thrombosis Angioplasty, Balloon Phase 4

Study Type: Observational
Official Title: Pilot Study Investigating the Use of a Variety of Assays to Detect Individual Response to Antiplatelet Therapy

Further study details as provided by NHS Greater Glasgow and Clyde:

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: September 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327041


Contacts
Contact: Richard IS Good, BA MBBS MRCP 0044 141 211 6390 richard_good@hotmail.com
Contact: Keith G Oldroyd, MBChB, MD, FRCP 0044 141 211 2337 keith.Oldroyd@northglasgow.scot.nhs.uk

Locations
United Kingdom
Western Infirmary Recruiting
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
  More Information

ClinicalTrials.gov Identifier: NCT00327041     History of Changes
Other Study ID Numbers: rgoodtrial001
First Submitted: May 15, 2006
First Posted: May 17, 2006
Last Update Posted: May 17, 2006
Last Verified: May 2006

Keywords provided by NHS Greater Glasgow and Clyde:
Aspirin
Clopidogrel
Balloon Angioplasty
Coronary Thrombosis

Additional relevant MeSH terms:
Thrombosis
Coronary Stenosis
Coronary Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases