Chlorthalidone and HCTZ Impacts on Platelet Activation

Creighton University

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Hydrochlorothiazide 25 mg; Drug: Aspirin 81 mg; Drug: Chlorthalidone 12.5 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02100462

13-16785

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Chlorthalidone 12.5 mg

Experimental group

Description:

Chlorthalidone 12.5 mg by mouth once daily for 2 weeks

Treatment:

Drug: Chlorthalidone 12.5 mg

Hydrochlorothiazide 25 mg

Experimental group

Description:

Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks

Treatment:

Drug: Hydrochlorothiazide 25 mg

Aspirin 81 mg

Active Comparator group

Description:

Aspirin 81 mg by mouth once daily for 2 weeks

Treatment:

Drug: Aspirin 81 mg