Clinical trial NCT00637078: STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)
Official title: Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Hypercholesterolemia
Keywords: hypertension
hypercholesterolemia
family physicians
fixed dose combination therapy
cluster randomized controlled trial
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-03-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary measures include the change at 6 months in SBP and DBP and cholesterol levels. These outcomes will be compared at the practice level
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Research Insititute
state: Ontario
Study officials:
affiliation: Deputy Director
name: Ross Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co prinicipal investigator
name: George Dresser, MD
role: PRINCIPAL_INVESTIGATOR
References: