ESH-CHL-SHOT: Blood pressure lowering and lipid lowering treatment after stroke

Phase 1

• Conditions: Patients with previous stroke (or transient ischaemic attack) and hypertension and hyperlipidaemia.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001757-21-SE
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-23
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

Stroke or transient ischaemic attack during the previous 1 to 6 months; Age 65 years or older; Hypertension (>140/90 mm Hg among untreated patients); Hyperlipidaemia (LDL-cholesterol >2.8 mmol/L among untreated patients)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7500

Exclusion Criteria

1) Significant carotid artery stenosis; 2) Secondary hypertension or treatment resistant hypertension; 3) Treatment resistant hyperlipidaemia; 4) Dementia; 5) Functional disability (modified Rankin Scale score >4); 6) Renal failure or liver disease; 7) Reduced compliance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the optimal level of blood pressure reduction (systolic blood pressure <125, <145-135 or <135-125 mm Hg) and lipid reduction (LDL-cholesterol <1.8 or <2.8-1.8 mmol/L) for the prevention of recurrent stroke.;Secondary Objective: To determine the optimal level of blood pressure reduction (systolic blood pressure <125, <145-135 or <135-125 mm Hg) and lipid reduction (LDL-cholesterol <1.8 or <2.8-1.8 mmol/L) for the prevention of other cardiovascular events, cognitive decline, dementia and neurological disability.;Primary end point(s): Recurrent stroke (fatal or non-fatal);Timepoint(s) of evaluation of this end point: Four years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cardiovascular events, non-fatal or fatal (stroke, myocardial infarction, vascular interventions, hospitalisation for heart failure); Cardiovascular deaths; All-cause deaths; Cognitive impairment; Dementia; Functional disability (modified Rankin Scale).;Timepoint(s) of evaluation of this end point: Four years