Status:
COMPLETED
Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis
Lead Sponsor:
Uppsala University
Conditions:
Coronary Artery Disease
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin a...
Detailed Description
To establish cut off levels of platelet inhibition using ADP-induced P2Y12-receptor mediated platelet aggregation using Accumetrics VerifyNow P2Y12 assay (PRU) and Vasodilator-stimulated phosphoprotei...
Eligibility Criteria
Inclusion
- Provide signed written informed consent.
- Male or female patients above 18 years old.
- Previous PCI and coronary stenting for coronary artery disease
- Previous (after coronary stenting) or current dual antiplatelet treatment (aspirin 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with aspirin 75 mg once daily at least seven days prior to enrollment.
- Experienced one of the following alternatives:
- Stent thrombosis within 6 months of PCI while on dual antiplatelet treatment; OR
- Experienced MI within 6 month after coronary stenting while on dual antiplatelet treatment; OR
- No experience of stent thrombosis or MI for at least 6 months and until visit 1 (matched control)
Exclusion
- General exclusion criteria:
- Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
- Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion
- Enrolled in either another investigational drug study or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
- Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine).
- Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion.
- UCR or Accumetrics employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Cardiovascular
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00914368
Start Date
January 1 2009
End Date
March 1 2010
Last Update
April 13 2010
Active Locations (1)
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1
Uppsala Clinical Research Center
Uppsala, Sweden, 75185