GM03 - Platelet RNA Signatures of Aspirin

• Status: Completed
• Trial end date: 2016-12-05
• Target enrollment: 0
• Participant gender: All

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 diabetes will be enrolled into protocol A.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

1. hypertension (requiring prescription medication).

2. hyperlipidemia (requiring medications)

3. Type 1 or 2 Diabetes