Chlorthalidone and HCTZ Impacts on Platelet Activation

Phase 4

• Conditions: Hypertension
• Interventions: Drug: Aspirin 81 mg; Drug: Chlorthalidone 12.5 mg; Drug: Hydrochlorothiazide 25 mg

• Registration Number: NCT02100462
• Lead Sponsor: Creighton University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aspirin 81 mg	Aspirin 81 mg	Aspirin 81 mg by mouth once daily for 2 weeks
Chlorthalidone 12.5 mg	Chlorthalidone 12.5 mg	Chlorthalidone 12.5 mg by mouth once daily for 2 weeks
Hydrochlorothiazide 25 mg	Hydrochlorothiazide 25 mg	Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in mean fluorescence intensity of PAC-1	2 weeks	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

Name	Time	Method
Change in CD62P expression	2 weeks	Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA.
Change in platelet aggregation	2 weeks	Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States