Phase
Condition
Healthy Volunteers
Treatment
T-TAS PL Assay
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Ostensibly Healthy Donors
Inclusion Criteria:
Males and females age 21 years or older.
Able and willing to provide written informed consent.
Exclusion
Exclusion Criteria:
Hospitalization or doctor's visits within prior 30 days, except for routinecheckup/physical examination.
Use of antiplatelet therapy within the past 7 days, e.g. aspirin, clopidogrel,prasugrel, ticagrelor, cilostazol.
Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin,warfarin, rivaroxaban, and apixaban.
Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 suchas naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibitplatelet activity (such as celecoxib).
History of anemia.
Known thrombocytopenia (platelet count < 100,000/μL).
Significant renal dysfunction or dialysis.
History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann'sthrombasthenia or Bernard-Soulier syndrome.
History of hemophilia or bleeding disorders.
Known active gastrointestinal disease including peptic ulcers, gastro-esophagealreflux disease (GERD), and hyperacidity.
Currently participating in a study involving an investigational drug or compoundknown to affect coagulation or hemostasis.
Subjects with significant past medical history as determined by the Investigatorthat would pose safety concerns or interfere with the study goals.
Antiplatelet Therapy Subjects
Inclusion Criteria:
Males and females age 21 years or older.
One of the following antiplatelet therapy regimens:
Aspirin monotherapy:
81 mg or higher aspirin daily for 1 or more days
Dual antiplatelet therapy:
81 mg or higher aspirin plus either 1) ≥300 mg clopidogrel loading dose within theprior 5 days followed by 75 mg daily clopidogrel, or 2) 75 mg daily clopidogreldaily for ≥5 days.
81 mg or higher aspirin plus either 1) 60 mg prasugrel loading dose within the prior 5 days followed by either 5 or 10 mg daily prasugrel, or 2) 5 or 10 mg dailyprasugrel daily for ≥5 days.
81 mg aspirin plus either 1) 180 mg ticagrelor loading dose within the prior 5 daysfollowed by 2x90 mg daily ticagrelor, or 2) 2x90 mg daily ticagrelor daily for ≥5days.
Able and willing to provide written informed consent.
Exclusion Criteria:
Use of antiplatelet therapy other than aspirin, clopidogrel, prasugrel, orticagrelor (e.g. cilostazol, abciximab, eptifibatide) within the past 7 days.
Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin,warfarin, rivaroxaban, and apixaban.
Significant renal dysfunction or dialysis.
Known thrombocytopenia (platelet count < 100,000/μL).
History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmannthrombasthenia or Bernard-Soulier syndrome.
History of hemophilia or bleeding disorders.
Females who are in the last trimester of pregnancy or are breastfeeding.
Known active gastrointestinal disease including peptic ulcers, gastro-esophagealreflux disease (GERD), and hyperacidity.
Currently participating in a study involving an investigational drug or compoundknown to affect coagulation or hemostasis.
Subjects with significant past medical history as determined by the Investigatorthat would pose safety concerns or interfere with the study goals.
Von Willebrand Disease Subjects
Inclusion Criteria:
Males and females age 21 years or older.
Prior diagnosis of von Willebrand disease type 1, 2A, 2B, 2M, or 3
Able and willing to provide written informed consent.
Exclusion Criteria:
Prior diagnosis of von Willebrand disease type 2N
Use of antiplatelet therapy besides aspirin within the past 14 days.
Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin,warfarin, rivaroxaban, and apixaban.
Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 suchas naproxen or ibuprofen within the past 7 days, unless confirmed to not inhibitplatelet activity (such as celecoxib).
Significant renal dysfunction or dialysis.
Known thrombocytopenia (platelet count < 100,000/μL).
Currently participating in a study involving an investigational drug or compoundknown to affect coagulation or hemostasis.
Subjects with significant past medical history as determined by the Investigatorthat would pose safety concerns or interfere with the study goals.
Study Design
Study Description
Connect with a study center
University of Florida Health Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United StatesActive - Recruiting
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