STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

University of Western Ontario, Canada1,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Hypertension Hypercholesterolemia

Interventions

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

initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination followed by a low dose DHP-CCB/statin combination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Robarts Research Insititute

London, Ontario, Canada

Outcomes

Primary Outcomes

Proportion of subjects whose systolic BP [SBP] <140 mmHg and diastolic BP [DBP] <90 mmHg)or proportion whose cholesterol levels are at or below threshold based on their global artherosclerotic risk profile compared at the practice level.

Time frame: 6 months

Secondary Outcomes

Secondary measures include the change at 6 months in SBP and DBP and cholesterol levels. These outcomes will be compared at the practice level

Time frame: 6 months

Data from ClinicalTrials.gov

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