STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

Phase 4

Completed

• Conditions: Hypertension; Hypercholesterolemia

• Registration Number: NCT00637078
• Lead Sponsor: University of Western Ontario, Canada

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-17
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Robarts Research Insititute; 🇨🇦 London, Ontario, Canada