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StrokePhase 4ESH-CHL-SHOTNCT01563731

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

A Phase 4 study testing all approved antihypertensive drugs; all approved statins in people with Stroke and Transient Ischemic Attack, run by Istituto Auxologico Italiano at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Stroke, Transient Ischemic Attack, Hypertension
What is being tested?
all approved antihypertensive drugs; all approved statins
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteRussia
Study dates
Apr 2013to 31 Mar 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Qualifying event: stroke or TIA 1 to 6 months previous to randomization.
  • All patients should have a CT scan or MRI (preferably MRI) at screening. The CT scan or MRI carried out at the time of the qualifying event, if available, is acceptable. Stroke will be defined as imaging evidence of a recent brain infarction (or haemorrhage) independently of duration of clinical symptoms, or as duration of clinical symptoms > 24 h even in absence of imaging evidence of lesion
  • TIA as clinical symptoms (involving limbs or speech) lasting < 24 h without imaging evidence of infarction. Enrolling units should avoid enrolling patients with TIA in a proportion greater than 25% of enrolled patients. The general coordinators in Milan and Beijing may decide stopping enrolment of TIA patients if their proportion is becoming greater than expected.
  • A haemorrhagic stroke (1 to 6 months previously) is also a qualifying event, but only for the BP-lowering component of the trial (see Exclusion criteria).
  • Age: 65 years and above. No fixed upper age limit is introduced, but frail patients aged above 80 years should not be enrolled.
  • Gender: either gender.
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  • BP: Only hypertensive patients: untreated patients with SBP ≥140 mmHg; patients on antihypertensive treatment with any BP (but see exclusion criteria)
  • LDL-C: Patients without statin treatment with LDL-C > 2.8 mmol/l; patients on statin treatment with any LDL-C value (but see exclusion criteria)
  • Antiplatelet therapy: All patients should be under antiplatelet therapy (agents and doses chosen by the investigator according to accepted guidelines), unless contraindicated. Anticoagulant (instead of antiplatelet) therapy whenever indicated (e.g. atrial fibrillation).

Who cannot join

  • Qualifying event:
  • Patients in unstable clinical conditions
  • Clinical disturbances caused by non-stroke pathology
  • patients with haemodynamically significant carotid stenosis or requiring carotid revascularization
  • haemorrhagic stroke is an exclusion criterion for the lipid lowering component of the trial; however, these patients should be randomized to the BP component, but considered in addition to the number of patients requested to each enrolling unit, in order not to decrease the power of the lipid-lowering component.
  • BP: - known secondary hypertension;
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  • SBP >140 mmHg under three antihypertensive drugs at full doses (these patients are unlikely to achieve SBP < 125 mmHg, if so randomized);
  • orthostatic hypotension (SBP fall > 25 mmHg on standing);
  • LDL-C: - LDL-C >2.8 mmol/l under full dose of a statin (these patients are unlikely to achieve LDL-C targets).
  • LDL-C > 4.5 mmol/l under low dose of a statin or untreated (these patients are unlikely to achieve the lower LDL-C target).
  • Others: - Patients with a myocardial infarction (preceding or subsequent to the qualifying stroke or TIA) if their baseline LDL-C is < 1.8 mmol/l
  • Dementia
  • Severe disability (modified Rankin scale > 4)
  • Severe chronic renal failure defined as serum creatinine > 250 micromol/l
  • Hepatic disease as determined by either AST or ALT values > 2 times the upper limit of normal
  • History of hepatic encephalopathy, esophageal varices or portocaval shunt
  • History of gastrointestinal surgery or disorders which could interfere with drug absorption
  • Known allergy or contraindications to one of the drugs to be administered in the study
  • History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years
  • History of clinically significant autoimmune disorders such as systemic lupus erythematosus
  • History of drug or alcohol abuse within the last 5 years
  • History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
  • Inability or unwillingness to give free informed consent

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Almazov Federal Heart, Blood and Endocrinology Centre

    Saint Petersburg, 197341

Other trials in Russia

About this study

Official title: European Society of Hypertension and Chinese Hypertension League Stroke in Hypertension Optimal Treatment Trial

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.

Read the detailed description

ESH-CHL-SHOT will randomize about 7500 participants aged > or = 65 years with SBP > or = 140 mmHg or antihypertensive therapy, who have presented a stroke or TIA, within 1 to 6 months before randomization.

The trial will investigate

  1. the effects of randomization to antihypertensive treatment of different intensities, aiming at three different SBP targets. SBP targets are < 145 to 135, < 135 to 125, < 125 mmHg, with approximate mean inter-target differences of 8 mmHg;
  2. the effects of randomization to lipid lowering treatment of different intensity, aiming at two different LDL-C targets. Targets are 2.8 to 1.8 mmol/l (110 to 70 mg/dl) and < 1.8 mmol/l;
  3. possible interactions between antihypertensive and lipid-lowering treatments. The primary hypothesis is that recurrent stroke rates will be 25% lower in the lowest vs intermediate SBP target group, 25% lower in the intermediate vs higher SBP target group, and 20% lower in the lower vs higher LDL-C target group. Sample size has been calculated to provide a 80% power with a significance of 5% after corrections for repetitive measurements on the assumption that stroke incidence will be 4% per year in the highest SBP target group. Participants will be recruited at approximately 250 clinics in Europe (2500 patients) and China (5000 patients) over a 2-year period, and will be followed up for an average of 4 years or until 925 recurrent strokes occur.

Arms and assigned intervention

  1. Antihypertensive treatment design and assigned treatment

Participants will be randomly allocated to one of three different sitting SBP targets:

  1. < 145 to 135 mmHg
  2. < 135 to 125 mmHg
  3. < 125 mmHg to be possibly achieved within 3 months and subsequently maintained within the target window.

Investigators are free to choose the drugs (among those approved in each country) to be administered to individual patients. It is expected that patients already on antihypertensive therapy and with SBP at randomization not too far from target will be maintained on current therapy with suitable adjustments. Other patients (untreated or with SBP far from target) may follow a suggested treatment algorithm of progressive increase in number of compounds or doses. During follow-up visits drugs and/or doses will be modified if necessary to maintain patients within randomized target window.

  1. Lipid-lowering treatment design and assigned treatment

Participants will be randomly allocated to one of two different LDL-C targets:

  1. 2.8 to 1.8 mmol/l (110 to 70 mg/dl) B) < 1.8 mmol/l (< 70 mg/dl) to be possibly achieved within 3 months and subsequently maintained within the target window.

Investigators are free to choose the statin (among those approved in each country) to be administered to individual patients. The initial statin dose should be chosen by the investigator according to LDL-C at randomization and the LDL-C target. The initial dose can be increased (to the maximum dose allowed in each country) or decreased until the LDL-C target is achieved possibly within 3 months, and further adjusted up or down at 6-month intervals in order to maintain LDL-C within the randomized target window.

Being tested
all approved antihypertensive drugs; all approved statins
Keywords
Blood pressure medicines, Lipid lowering medicines, Hypertension, Stroke, Dementia, Heart attack, Heart failure
Medical subject headings
Stroke, Ischemic Attack, Transient, Hypertension, Dementia, Myocardial Infarction, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • all approved antihypertensive drugs; all approved statinsDrug

    Also called Calcium channel blockers, Angiotensin converting enzyme inhibitors, Angiotensin receptor blockers, Thiazide diuretics

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

Study groups in NCT01563731
Study groupRoleWhat they receive
SBP < 145-135 mmHg and LDL-C 2.8 - 1.8 mmol/lOtherHighest SBP target. Higher LDL-C target. Control arm
Receives: Drug: all approved antihypertensive drugs; all approved statins
SBP < 135-125 mmHg and LDL-C 2.8 - 1.8 mmol/lActive comparatorIntermediate SBP target. Higher LDL-C target .
Receives: Drug: all approved antihypertensive drugs; all approved statins
SBP < 125 mmHg and LDL-C 2.8 - 1.8 mmol/lActive comparatorLowest SBP target. Higher LDL-C target
Receives: Drug: all approved antihypertensive drugs; all approved statins
SBP < 145-135 mmHg and LDL-C < 1.8 mmol/lActive comparatorHighest SBP target. Lower LDL-C target.
Receives: Drug: all approved antihypertensive drugs; all approved statins
SBP < 135-125 mmHg and LDL-C < 1.8 mmol/lActive comparatorIntermediate SBP target. Lower LDL-C target.
Receives: Drug: all approved antihypertensive drugs; all approved statins
SBP < 125 mmHg and LDL-C < 1.8 mmol/lActive comparatorLowest SBP target. Lower LDL-C target.
Receives: Drug: all approved antihypertensive drugs; all approved statins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent stroke

    Time to occurrence of (recurrent) stroke (fatal and non fatal)

    Measured: five years

Secondary outcomes (2)

  1. Major cardiovascular (CV) events

    First major cardiovascular events, a composite of CV death, non fatal stroke, non fatal myocardial infarction, vascular intervention, hospitalized heart failure

    Measured: five years

  2. Cognitive impairment and dementia

    Cognitive impairment (decline in Montreal Cognitive Assessment Test); Dementia (Disability Assessment for Dementia)

    Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2012 (estimated)
  2. Study startApr 2013
  3. Primary completion31 Dec 2020
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563731
Sponsor's protocol ID
27F201
Acronym
ESH-CHL-SHOT
Status last verified
Feb 2024
First submitted
20 Mar 2012
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

    PubMed 36398903

  • Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

    PubMed 32905623

  • Zanchetti A, Liu L, Mancia G, Parati G, Grassi G, Stramba-Badiale M, Silani V, Bilo G, Corrao G, Zambon A, Scotti L, Zhang X, Wang H, Zhang Y, Zhang X, Guan TR, Berge E, Redon J, Narkiewicz K, Dominiczak A, Nilsson P, Viigimaa M, Laurent S, Agabiti-Rosei E, Wu Z, Zhu D, Rodicio JL, Ruilope LM, Martell-Claros N, Pinto F, Schmieder RE, Burnier M, Banach M, Cifkova R, Farsang C, Konradi A, Lazareva I, Sirenko Y, Dorobantu M, Postadzhiyan A, Accetto R, Jelakovic B, Lovic D, Manolis AJ, Stylianou P, Erdine S, Dicker D, Wei G, Xu C, Xie H, Coca A, O'Brien J, Ford G. Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomized trial. J Hypertens. 2014 Sep;32(9):1888-97. doi: 10.1097/HJH.0000000000000254.

    PubMed 24979303

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing all approved antihypertensive drugs; all approved statins in people with Stroke and Transient Ischemic Attack, run by Istituto Auxologico Italiano at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent stroke (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563731, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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