GM03 - Platelet RNA Signatures of Aspirin

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT05278637
Collaborator
(none)
135
Enrollment
1
Location
3
Arms
37.1
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Early Phase 1

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 at the DCRU using two separate cohorts: 1) healthy adult volunteers 2) patients with Type 2 diabetes. Subjects within each cohort will but in general will have platelet function testing and biospecimen collection before, four weeks, and eight weeks after low- or high-dose aspirin exposure. Subsequently there will be a period of aspirin washout and a four-week exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points peripheral blood RNA, purified platelets, DNA, serum, fecal samples and/or plasma will be collected.

Protocol B This will be a single arm study of the platelet inhibitor ticagrelor that is essentially the last two visits of Protocol A. This study will be conducted at the DCRU and will only be open to healthy adult volunteers and patients with Type 2 diabetes. Subjects who elect to participate in this protocol will follow the protocol outlined in Figure 2 and in general will have platelet function testing and biospecimen collection before and four weeks after exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at various time points (see Figure 2 and Table 2) peripheral blood RNA, purified platelets, DNA, serum, and/ plasma will be collected. In order to align the visits with that of Protocol A, the two visits under this protocol will be labelled V4 and V5.

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks. Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks. Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
DEVELOPMENT OF PROGNOSTIC PLATELET RNA BIOMARKERS TO TAILOR ANTIPLATELET THERAPY
Actual Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Dec 5, 2016
Actual Study Completion Date :
Dec 5, 2016

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Aspirin 81mg/day, Aspirin 325mg/day, Aspirin washout, Ticagrelor 90mg BID

Drug: Aspirin
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.

Drug: Ticagrelor
Ticagrelor 90mg BID x 4 weeks

Active Comparator: Aspirin 325mg/day, Aspirin 81mg/day, Aspirin washout, Ticagrelor 90mg BID

Drug: Aspirin
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.

Drug: Ticagrelor
Ticagrelor 90mg BID x 4 weeks

Active Comparator: Ticagrelor 90mg BID

Drug: Ticagrelor
Ticagrelor 90mg BID x 4 weeks

Outcome Measures

Primary Outcome Measures

  1. Change in expression levels of platelet messenger RNA [Baseline, after every 4 week exposure]

Secondary Outcome Measures

  1. Change in platelet function score [Baseline, 3 hours, after every 4 week exposure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Duke UniversityDurhamNorth CarolinaUnited States27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Deepak Voora, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05278637
Other Study ID Numbers:
  • Pro00048621
First Posted:
Mar 14, 2022
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022