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NCT00327041 Clinical Trial

Monitoring Response to Antiplatelet Therapy

Coronary Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00327041
Other study ID # rgoodtrial001
Secondary ID
Status Recruiting
Phase Phase 4
First received May 15, 2006
Last updated May 15, 2006
Start date January 2006
Est. completion date September 2006

Study information
Verified date May 2006
Source NHS Greater Glasgow and Clyde
Contact Richard IS Good, BA MBBS MRCP
Phone 0044 141 211 6390
Email richard_good@hotmail.com
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Western Infirmary Glasgow Scotland

Sponsors (1)
Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

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