Status:
COMPLETED
Reversibility of Dual Antiplatelet Therapy by Platelets
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Novo Nordisk A/S
CSL Behring
Conditions:
Bleeding
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
The objective of the study is to test the hypothesis whether or not autologous stored platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed by state-of-the-art pl...
Detailed Description
Dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to prevent thrombotic complications in patients with high platelet reactivity following plaque rupture in acute co...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent
- Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted)
- Age of consent
- Weight: 70 kg - 100 kg
- Platelet count 240 000 to 440 000/µL
- Hematocrit \> 40%
- readiness to refrain from any activities prone to injury during the study period.
- Exclusion criteria:
- Allergy against aspirin or clopidogrel
- History of bleeding
- History of peptic ulcer
- Intake of aspirin or NSAR during the last ten days before screening
- Gastrointestinal disease precluding resorption of aspirin and clopidogrel
- Scheduled surgery
- Any current medication
- History of hepatic disease
- 20µm ADP induced aggregation \< 60% at screening
- CYP2C19 polymorphisms
- Donation of blood within the preceding 4 weeks
- Neurotic disease
- Current smoking
- Drug addiction
- Intake of grapefruits during the last 10 days before
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01248351
Start Date
November 1 2010
End Date
March 1 2011
Last Update
April 28 2011
Active Locations (1)
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1
Department of anesthesia and intensive care medicine, Medical Univerity of Graz
Graz, Austria, 8036