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Optimal Blood Pressure and Cholesterol Targets for Preventing Recurrent Stroke in Hypertensives

NCT01563731 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-20

No results posted yet for this study

Summary

Stroke is one of the major causes not only of mortality, but of disease burden worldwide, because of residual disability and cognitive decline. Although blood pressure lowering has been clearly shown to be the most effective means for primary and secondary prevention of stroke, the systolic blood pressure (SBP) levels to achieve by treatment in order to optimize prevention results are unknown, and whether SBP levels lower than those usually recommended are accompanied by further or reduced benefits is undecided yet. Likewise, while low-density lipoprotein cholesterol (LDL-C) lowering by statins has been shown to be associated with primary and secondary stroke prevention, whether more intense lowering is or is not of further benefit is unknown. The Stroke in Hypertension Optimal Treatment Trial (ESH-CHL-SHOT) is a factorial 3 x 2 arm, multicenter, randomized clinical trial designed to test the hypothesis that in elderly patients at high risk of recurrent stroke (previous recent stroke or TIA) antihypertensive treatment programs aimed at reducing SBP to the usually recommended values (\< 145 to 135 mmHg), to a lower goal (\< 135 to 125 mmHg) or to even lower values (\< 125 mmHg) will result in progressively greater reductions in recurrent stroke, incidence of cardiovascular outcomes and cognitive decline. Parallely, the preventive efficacy of more and less intense LDL-C reductions will be tested on the same outcomes.

Conditions

Interventions

DRUG

all approved antihypertensive drugs; all approved statins

All drugs to be used at doses capable of bringing SBP and LDL-C to targets; only doses approved in each country.

Sponsors & Collaborators

  • European Society of Hypertension

    collaborator OTHER

  • Chinese Hypertension League

    collaborator UNKNOWN

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Alberto Zanchetti · Istituto Auxologico Italiano

  • Lisheng Liu, MD · Beijing Hypertension League Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563731 on ClinicalTrials.gov