STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

University of Western Ontario, Canada

Status and phase

Completed

Phase 4

Conditions

Hypertension

Hypercholesterolemia

Treatments

Other: Treatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00637078

RPO702

Details and patient eligibility

About

The objective of this study is to assess if the implementation of a treatment algorithm including initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination and subsequently a low dose DHP-CCB/statin combination will improve the management of hypertension/hypercholesterolemia compared to guidelines-base management at family practices.

Full description

Utilization of fixed dose combination therapy has been advocated as an adherence-enhancing strategy and has been so recommended in the 2007 Canadian Hypertension Education Program (CHEP) recommendations. Further, in a previous study (STITCH) it was demonstrated that a simplified treatment algorithm utilizing initial therapy with a low dose fixed-dose combination therapy improved blood pressure control in hypertensive patients. However, the effectiveness of either a simplified treatment algorithm or the initial use of fixed dose combination therapies for 2 risk factors in hypertensive dyslipidemic patients has yet to be determined. Therefore, the current study is designed to determine whether utilization of a fixed dose combination hypertension/hypercholesterolemia therapy results in improved adherence, patient satisfaction as well as improved rates of reaching target LDL cholesterol and blood pressure.

Enrollment

1,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male or female subjects 18 years or older
documented diagnoses of hypertension and of hypercholesterolemia or current therapy for these conditions
uncontrolled hypertension (SBP >140 mmHg or DBP >90 mmHg) or cholesterol levels above their threshold based on their global atherosclerotic risk profile (based on ATP III assessment)
ability to give written informed consent

Exclusion criteria

ischemic heart disease, atrial fibrillation, chronic kidney disease and significant liver disease
currently prescribed 3 or more drugs to control blood pressure
currently prescribed 2 or more drugs to control hypercholesterolemia
participating in other hypertension/hypercholesterolemia studies