Status:
COMPLETED
GM03 - Platelet RNA Signatures of Aspirin
Lead Sponsor:
Duke University
Conditions:
Platelet Aggregation Inhibitors
Aspirin
Eligibility:
All Genders
30-75 years
Phase:
EARLY_PHASE1
Brief Summary
This study will involve healthy volunteers and patients with Type 2 diabetes. Eligible healthy volunteers will be invited to enroll into one of two protocols (A or B) and eligible patients with diabet...
Detailed Description
Protocol A This will be a randomized, cross-over design comparing low- and high-dose aspirin as well as a non-aspirin platelet inhibitor ticagrelor. This antiplatelet exposure study will be conducted ...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Age ≥ 30 and ≤ 75
- Non-smoker
- The total number of enrolled females should not exceed 55% of the entire cohort. Therefore, the PI may include/exclude individuals on the basis of gender to achieve an equal balance between men and women.
Exclusion
- History of bleeding disorder, gastrointestinal bleeding, intracranial bleeding or known prior gastric ulcer without documented resolution
- Current regular use of antiplatelet agents (aspirin, cilostazol, prasugrel, clopidogrel, dipyridamole, ticagrelor, or ticlopidine), nonsteroidal anti-inflammatory agents (NSAIDs), oral corticosteroids (i.e. prednisone), anticoagulants (warfarin, dabigatran, apixaban, rivaroxaban, enoxaparin)
- Known, severe hepatic impairment
- Surgery within the last 6 months, at the discretion of the PI
- Prior gastric bypass surgery (or equivalent) that interferes with absorbption at the discretion of the PI
- Aspirin allergy or known intolerance to aspirin or ticagrelor.
- Comorbid conditions:
- hypertension (requiring prescription medication).
- hyperlipidemia (requiring medications)
- Type 1 or 2 Diabetes
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2016
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05278637
Start Date
November 1 2013
End Date
December 5 2016
Last Update
March 14 2022
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705