NCT02100462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Mar 2014

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

March 27, 2014

Last Update Submit

December 10, 2015

Conditions

Hypertension

Keywords

HypertensionPlatelet activationPlatelet aggregationChlorthalidone

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (2)

  • Change in CD62P expression

    2 weeks

  • Change in platelet aggregation

    2 weeks

Study Arms (3)

Chlorthalidone 12.5 mg

EXPERIMENTAL

Chlorthalidone 12.5 mg by mouth once daily for 2 weeks

Drug: Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg

EXPERIMENTAL

Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks

Drug: Hydrochlorothiazide 25 mg

Aspirin 81 mg

ACTIVE COMPARATOR

Aspirin 81 mg by mouth once daily for 2 weeks

Drug: Aspirin 81 mg

Interventions

Chlorthalidone 12.5 mgDRUG
Chlorthalidone 12.5 mg
Hydrochlorothiazide 25 mgDRUG
Hydrochlorothiazide 25 mg
Aspirin 81 mgDRUG
Aspirin 81 mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36067089DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

ChlorthalidoneHydrochlorothiazideAspirin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesThiazidesSalicylatesHydroxybenzoatesPhenols

Study Officials

  • Khalid Bashir, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy Byers, RN

CONTACT

402-280-4961sandrabyers@creighton.edu

Caroline Nubel, BS

CONTACT

402-280-4032carolinenubel@creighton.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(1)