Stable Angina Clinical Trial
Official title:
Prospective Pilot Study- Does Mean Platelet Volume Change With Clopidogrel in Patients With Stable Angina Undergoing Percutaneous Coronary Intervention?
Platelets play a major role in thrombus formation and platelet size, measured by Mean
Platelet Volume (MPV) correlates with platelet activity. MPV is increased in patients with
Myocardial Infarction (MI) and is an independent predictor of adverse events in patients
with ST Elevation Myocardial Infarction (STEMI) . Data on MPV in patients with stable angina
is limited.
Aspirin and clopidogrel are antiplatelet agents administered routinely to patients
undergoing PCI and are required for stent patency. MPV is not known to be affected by low
dose Aspirin. Treatment with clopidogrel is thought to reduce MPV in-vitro but the magnitude
of this reduction in MPV is unclear, especially in patients with stable angina undergoing
PCI. An inverse correlation also exists between MPV and platelet count .
The investigators aim to assess if a change occurs in MPV (∆ MPV) after routine clopidogrel
administration in patients with stable angina undergoing PCI.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - > 18 years old - Able to attend for follow up blood tests - Able to provide written informed consent Exclusion Criteria: - <18 years of age - Unable to attend for follow up blood tests on days 1, 7 and 30 - Already on clopidogrel at least 1 day prior to presenting for angiography/PCI - Those who undergo only diagnostic angiography - History of Myocardial Infarction (MI) in last 1 year - Anemia (Hb<100) - Abnormal (low or high out of range) platelet counts - Diabetes Mellitus - Known liver disease - Known severe renal impairment (eGFR <30ml/min/1.73m2) - Known pregnancy - On Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or steroids - Known connective tissue disease - Acute ongoing infections or bleeding - On oral anticoagulant treatment in the last 1 week - Pro-coagulant blood disorder - Known immunosuppressed states - Treatment with GpIIb/IIIa inhibitor in the last week prior to presentation - Patients involved in other trials |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in MPV (?MPV) with clopidogrel in stable angina patients undergoing PCI. | 30 days | No | |
Secondary | Change in Platelet count (? platelet count) with clopidogrel in stable angina patients | 30 days | No | |
Secondary | Correlation between ?MPV and adverse events (readmission and Myocardial Infarction) at 30 days | 30 days | No |
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