GM03 - Platelet RNA Signatures of Aspirin

NCT05278637 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Pro00048621
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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 diabetes will be enrolled into protocol A.

Conditions

Platelet Aggregation Inhibitors; Aspirin; Ticagrelor; RNA

Outcome Measures

Primary Outcomes (1)

• Change in expression levels of platelet messenger RNA

  Baseline, after every 4 week exposure

Secondary Outcomes (1)

• Change in platelet function score

  Baseline, 3 hours, after every 4 week exposure

Study Arms (3)

Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID

ACTIVE COMPARATOR

Drug: Aspirin; Drug: Ticagrelor

Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID

ACTIVE COMPARATOR

Drug: Aspirin; Drug: Ticagrelor

Ticagrelor 90mg BID

ACTIVE COMPARATOR

Drug: Ticagrelor

Interventions

Aspirin DRUG

Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks. or Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks.

Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID; Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID

Ticagrelor DRUG

Ticagrelor 90mg BID x 4 weeks

Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID; Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID; Ticagrelor 90mg BID

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Aspirin; Ticagrelor

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Deepak Voora, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks. 2. Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: November 1, 2013
• Primary Completion: December 5, 2016
• Study Completion: December 5, 2016
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)