STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

Condition(s) targeted: Hypertension; Hypercholesterolemia

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

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Robarts Research Institute

Official(s) and/or principal investigator(s):
Ross Feldman, MD, Principal Investigator, Affiliation: Deputy Director
George Dresser, MD, Principal Investigator, Affiliation: Co prinicipal investigator

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.

Official title: Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: 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.

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Robarts Research Insititute, London, Ontario N6A 5K8, Canada

Starting date: February 2008
Ending date: March 2009
Last updated: March 14, 2008