Monitoring Response to Antiplatelet Therapy
Primary Purpose
Coronary Stenosis, Coronary Thrombosis, Angioplasty, Balloon
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Coronary Stenosis focused on measuring Aspirin, Clopidogrel, Balloon Angioplasty, Coronary Thrombosis
Eligibility 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.
Sites / Locations
- Western InfirmaryRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00327041
First Posted
May 15, 2006
Last Updated
May 15, 2006
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT00327041
Brief Title
Monitoring Response to Antiplatelet Therapy
Official Title
Pilot Study Investigating the Use of a Variety of Assays to Detect Individual Response to Antiplatelet Therapy
Study Type
Observational
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Coronary Thrombosis, Angioplasty, Balloon
Keywords
Aspirin, Clopidogrel, Balloon Angioplasty, Coronary Thrombosis
7. Study Design
Enrollment
40 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard IS Good, BA MBBS MRCP
Phone
0044 141 211 6390
Email
richard_good@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Keith G Oldroyd, MBChB, MD, FRCP
Phone
0044 141 211 2337
Email
keith.Oldroyd@northglasgow.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith G Oldroyd, MBChB, MD, FRCP
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Monitoring Response to Antiplatelet Therapy
We'll reach out to this number within 24 hrs