Status:
COMPLETED
Platelet Function Monitoring in Patients Treated With Clopidogrel at the Time of Primary Percutaneous Coronary Angioplasty
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Platelet Reactivity
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
Platelets are a major component of clot formation which can lead to clotting events such as heart attack. During treatment for a heart attack, doctors try to remove this blockage as quickly as possibl...
Detailed Description
Platelets are a major component of clot formation which can lead to thrombotic events. Antiplatelet agents have been found to reduce cardiovascular events in different clinical settings. The commonest...
Eligibility Criteria
Inclusion
- Ischemic chest discomfort of greater than 30 minutes duration
- Onset of chest pain less than 12 hrs prior to entry into the study
- ST segment elevation of \> 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old
Exclusion
- Active bleeding
- GI or GU bleed within 2 weeks, or any major bleeding episode within 2 weeks
- Stroke within 90 days or intracranial bleeding at any time
- Major surgery or trauma within the past six weeks
- Uncontrolled hypertension (SBP \> 200 mm Hg and/or DBP \> 110 mm Hg despite treatment)
- Prolonged (\>10 min) cardiopulmonary resuscitation
- Inadequate vascular access
- PCI within the last 30 days
- Thrombolytic agents within the preceding 7 days
- GP IIb/IIIa antagonists within the preceding 7 days
- Coagulation disorder (i.e. INR \>2.0, platelets \<100,000 / mm3, or hematocrit \<30%)
- Current warfarin treatment
- A subcutaneous therapeutic dose of any LMWH within 12 hours
- Intolerance to aspirin or clopidogrel
- Patient already on chronic clopidogrel therapy
- Other medical condition that is likely to result in death within 12 months
- Participation in a study with another investigational device or drug \< four weeks
- Pregnancy
- Known severe renal impairment (creatinine clearance rate of less than 30 ml per minute)
- Sustained hypotension defined as SBP \< 80 mmHg or the need for IV inotropes and/or intraaortic balloon counterpulsation to support the blood pressure
- Known severe contrast (dye) allergy
- Inability to provide informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00827346
Start Date
January 1 2009
End Date
April 1 2011
Last Update
April 29 2011
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7