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Chlorthalidone and HCTZ Impacts on Platelet Activation

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorthalidone 12.5 mg
Hydrochlorothiazide 25 mg
Aspirin 81 mg
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Platelet activation, Platelet aggregation, Chlorthalidone

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men or women age 19 or older
  • Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements
  • No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period
  • Systolic blood pressure > 110 mmHg and diastolic blood pressure > 60 mmHg
  • Non-smoker

Exclusion Criteria:

  • Previous adverse reaction or allergy to HCTZ, CTD, or ASA
  • Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome)
  • Diagnosis of any chronic disease or condition
  • History of gout or hyperuricemia
  • History of pancreatitis
  • History of systemic lupus erythematosus (SLE)
  • History of hypokalemia requiring treatment
  • Pregnant or planning to become pregnant during the study period
  • Breastfeeding
  • History of hypotension
  • History of gastrointestinal bleeding

Sites / Locations

  • Creighton UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg

Aspirin 81 mg

Arm Description

Chlorthalidone 12.5 mg by mouth once daily for 2 weeks

Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks

Aspirin 81 mg by mouth once daily for 2 weeks

Outcomes

Primary Outcome Measures

Change in mean fluorescence intensity of PAC-1
The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin.

Secondary Outcome Measures

Change in CD62P expression
Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.
Change in platelet aggregation
Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA

Full Information

First Posted
March 27, 2014
Last Updated
December 10, 2015
Sponsor
Creighton University
Collaborators
Dialysis Clinic, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02100462
Brief Title
Chlorthalidone and HCTZ Impacts on Platelet Activation
Official Title
Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
Dialysis Clinic, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is that CTD has different effects on platelet activation and aggregation than HCTZ.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Platelet activation, Platelet aggregation, Chlorthalidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorthalidone 12.5 mg
Arm Type
Experimental
Arm Description
Chlorthalidone 12.5 mg by mouth once daily for 2 weeks
Arm Title
Hydrochlorothiazide 25 mg
Arm Type
Experimental
Arm Description
Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks
Arm Title
Aspirin 81 mg
Arm Type
Active Comparator
Arm Description
Aspirin 81 mg by mouth once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Chlorthalidone 12.5 mg
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide 25 mg
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Primary Outcome Measure Information:
Title
Change in mean fluorescence intensity of PAC-1
Description
The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in CD62P expression
Description
Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.
Time Frame
2 weeks
Title
Change in platelet aggregation
Description
Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men or women age 19 or older Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period Systolic blood pressure > 110 mmHg and diastolic blood pressure > 60 mmHg Non-smoker Exclusion Criteria: Previous adverse reaction or allergy to HCTZ, CTD, or ASA Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome) Diagnosis of any chronic disease or condition History of gout or hyperuricemia History of pancreatitis History of systemic lupus erythematosus (SLE) History of hypokalemia requiring treatment Pregnant or planning to become pregnant during the study period Breastfeeding History of hypotension History of gastrointestinal bleeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Byers, RN
Phone
402-280-4961
Email
sandrabyers@creighton.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Nubel, BS
Phone
402-280-4032
Email
carolinenubel@creighton.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Bashir, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Byers, RN
Phone
402-280-4961
Email
sandrabyers@creighton.edu
First Name & Middle Initial & Last Name & Degree
Tammy L Burns, PharmD, BCPS
First Name & Middle Initial & Last Name & Degree
Khalid Bashir, MD
First Name & Middle Initial & Last Name & Degree
Michael White, MD
First Name & Middle Initial & Last Name & Degree
Daniel E Hilleman, PharmD
First Name & Middle Initial & Last Name & Degree
Venkata M Alla, MD
First Name & Middle Initial & Last Name & Degree
Venkata Andukuri, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
36067089
Citation
Bashir K, Burns T, Pirruccello SJ, Aurit SJ, Hilleman DE. Comparative antiplatelet effects of chlorthalidone and hydrochlorothiazide. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1310-1315. doi: 10.1111/jch.14564. Epub 2022 Sep 6.
Results Reference
derived

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Chlorthalidone and HCTZ Impacts on Platelet Activation

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