Brain IschemiaTICANCT03491449
Intensive Treatment of Blood Pressure in Acute Ischemic Stroke. Study TICA 2
A study testing Group A and Group B in people with Brain Ischemia, run by Manuel Rodríguez at 3 sites in Spain.
Trial summary
Demonstrate that maintenance of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management according to the International Guideline (treat when systolic blood pressure exceeds 185 mm Hg) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- Group A and Group B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesSpain
- Study dates
- 13 Feb 2017to 13 Feb 2020
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 years and up to and 85 years (both included).
- Clinical and neuroimaging diagnosis (CT or MRI) of ischemic stroke.
- Possibility of initiating antihypertensive treatment within 12 hours after the onset of symptoms (in the case of stroke, the start time is considered the time in that the patient has been seen asymptomatic for the last time).
- Participant with systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 220 mm Hg at the time of inclusion.
- Participant or legal representative able to understand the study requirements and sign Informed consent.
Who cannot join
- Uncontrollable hypertension (SBP greater than 220 mm Hg) or any condition requiring urgent antihypertensive treatment.
- Have suffered a stroke in the previous 90 days in the same territory as the current stroke.
- Had a myocardial infarction in the previous 90 days.
- Suspected aortic dissection or hypertensive encephalopathy.
- Presence of intracerebral or subarachnoid hemorrhage in basal neuroimaging (Computed tomography or magnetic resonance imaging).
- Recanalization is possible or intraarterial recanalization techniques have been performed due to the current stroke.
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- Known critical carotid occlusion or stenosis.
- To be a candidate for carotid revascularization in the next three months.
- Previous alterations that, in the opinion of the investigator, may interfere in the interpretation of the neurological scales.
- Coma or low level of consciousness (defined as a score ≥ 2 in section 1.a of NIHSS), dementia or mental disability that, in the opinion of the investigator, patient is unable to participate in the study.
- Convulsive seizures at any time from the onset of symptoms to the initial evaluation.
- Neurological or non-neurological comorbidities that, in the opinion of the investigator, may lead, regardless of the current stroke, to a deterioration in the patient's neurologic status during the study period, or may hinder the evaluation of the neurological state caused only by stroke (i.e., metabolic encephalopathies, hemiplegic migraine, multiple sclerosis, central nervous system tumor, epilepsy, monocular blindness).
- Patient is likely to undergo a procedure involving extracorporeal circulation during the study period.
- Any condition that, in the opinion of the investigator, may compromise the patient's ability to complete the study (i.e., concomitant diseases that may threaten the patient's life, such as neoplasms or terminal failure of an organ).
- Patient's previous disability, determined by a score in modified Rankin scale > 1.
- Women of childbearing age with positive pregnancy test or breastfeeding at the time of inclusion.
- Women of childbearing potential (menopause less than 2 years old or not surgically sterilized) who are not going to take effective and adequate measures to avoid conception during the study period. Control measures include hormonal contraceptives, barrier methods such as diaphragm or intrauterine devices and / or spermicidal preservatives.
- Current dependence on substances of abuse such as alcohol, sympathomimetic amines, cannabis, cocaine, hallucinogens, opioids, phencyciclin, sedatives or hypnotics.
- Life expectancy is less than the expected duration of the clinical trial or any situation that, at the discretion of the investigator, may make participation in the clinical trial dangerous (eg drug use, alcohol addiction, etc.).
- Have received a drug or product under or participate in a clinical trial within 30 days prior to the date of inclusion in the study.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario A Coruña
A Coruña, 15006
Mª Dolores Fernandez, MD, MA.Dolores.Fernandez.Couto@sergas.es
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Manuel Yañez, MD, manyanez@yahoo.es
- Recruiting
Hospital Universitario Álvaro Cunqueiro
Vigo, Pontevedra, 36312
José Luís Maciñeiras, MD, jlmacmon@hotmail.com
About this study
Demonstrate that maintenance of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management according to the International Guideline (treat when systolic blood pressure exceeds 185 mm Hg)
Read the detailed description
Control of blood pressure figures remains one of the most important risk factors in primary and secondary prevention in patients with stroke. The current strategy for the hypertensive treatment of patients during the acute phase of ischemic stroke within the first 72 hours remains a highly debated and unclear issue, with no consensus on the range or appropriate blood pressure ranges to be handled (13).
Team study working hypothesis focuses on the study of blood pressure (for 72 hours), through its intensive control (recording and adjustment every four hours), in the acute phase of ischemic stroke. Specifically, it is based on the monitoring and maintenance of systolic blood pressure between 140 and 160 mm Hg in patients with acute ischemic stroke; And this can lead to a better functional prognosis, measured at 90 days, compared with the functional prognosis of patients treated according to the recommendations of the current Clinical Guidelines, which propose to act on systolic blood pressure only when it exceeds 185 mm Hg (13,22).
Although the intense decrease in blood pressure during the acute phase of stroke has the potential risk of decreasing cerebral perfusion in the area of ischemic penumbra, in recent observational studies (19), a worse functional prognosis has not been found in those patients With systolic blood pressure above 140 mm Hg.
There is no previous evidence from other intervention studies related to blood pressure control and a benefit to patients with acute ischemic stroke. Comparison using a randomized clinical trial of a group of patients with blood pressure control following current guidelines with a group of patients with systolic blood pressure between 140 and 160 mm Hg may allow a simple, rapidly applicable therapeutic alternative to Clinical practice, low cost and extrapolable to a wider population, such as patients with stroke of any etiology.
- Conditions
- Brain Ischemia
- Being tested
- Group A, Group B
- Keywords
- Brain ischemia, Cerebral ischemia
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AProcedure or surgery
Maintaining a systolic blood pressure ≥ 140 and ≤ 160mm Hg for 72 hours.
Group BProcedure or surgery
Maintaining a systolic blood pressure <185mm Hg for 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group A: pressure ≥140 and ≤160mmHg | Experimental | Intensive management of blood pressure, maintaining a systolic blood pressure ≥ 140 and ≤ 160 mm Hg for 72 hours. Receives: Procedure: Group A |
| Group B: Keep systolic pressure <185mmHg | Active comparator | Intensive management of blood pressure, maintaining systolic blood pressure <185 mm Hg for 72 hours. Receives: Procedure: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin scale measured at 90 ± 15 days will compared between the two branches.Rankin Scale: It is a scale that evaluates the patient's functional situation. The full name is "modified Rankin Scale", and the abbreviated name is "mRS". The range of the scale is from 0 to 6, where 0 is the best score (the patient is asymptomatic) and 6 is the worst score (mortality). Up to 2 the patient is considered independent, and from 3 the patient needs help for the activities of daily life.
Measured: 90 days
Secondary outcomes (5)
Early Neurological Impairment (ENI)
Increased at 4 or more points on the NIHSS scale in any determination during the first 72 hours compared to baseline score. NIHSS Scale: It is a scale that evaluates the neurological situation of the patient. The full name is "National Institute of Health Stroke Scale." The lowest score is 0, and the upper limit is 40. The lower score, the patient has fewer symptoms, and the higher score, the patient is more serious. It is considered that up to 8 points the patient has a mild stroke, between 8-15 a moderate stroke and more than 16 points a severe stroke.
Measured: 72 hours
Volume of the infarct in neuroimaging
Volume of the infarct in neuroimaging (CT or MRI) performed between the 4th and 7th day after the stroke. The volume in mL, using the formula a x b x c x 0.5, where "a" and "b" are the largest diameters perpendicular in centimeters and "c" the number of 1 cm cuts in which the infarct is seen.
Measured: 4th day
Mortality
Any patient who dies from inclusion (signature of informed consent) until the final study visit (90 ± 15 days).
Measured: 90 days
Measuring the adverse events
Measuring the adverse events occurring throughout the study.
Measured: 90 days
Volume of the infarct using NIHSS
Increased at 4 or more points on the NIHSS scale in any determination during the first 72 hours compared to baseline score. NIHSS Scale: It is a scale that evaluates the neurological situation of the patient. The full name is "National Institute of Health Stroke Scale." The lowest score is 0, and the upper limit is 40. The lower score, the patient has fewer symptoms, and the higher score, the patient is more serious. It is considered that up to 8 points the patient has a mild stroke, between 8-15 a moderate stroke and more than 16 points a severe stroke.
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start13 Feb 2017
- Primary completion13 Feb 2019 (estimated)
- Study completion13 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, multicenter, open, two-parallel groups, randomized 1: 1
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manuel Rodríguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Rodríguez, Hospital Clinico Universitario de Santiago
- Investigators
- Manuel Rodríguez, MD, Principal investigator, Hospital Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491449
- Sponsor's protocol ID
- MRY-IIA-2015-01
- Acronym
- TICA
- Status last verified
- Apr 2018
- First submitted
- 6 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Treatment of Blood Pressure in Acute Ischemic Stroke. Study TICA 2
- ClinicalTrials.gov ID
- NCT03491449
- Acronym / sponsor ID
- TICA / MRY-IIA-2015-01
- Conditions
- Brain Ischemia
- Keywords
- Brain ischemia, Cerebral ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Manuel RodríguezUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 13 Feb 2019 (estimated)
- Study completion
- 13 Feb 2020 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate that maintenance of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management according to the International Guideline (treat when systolic blood pressure exceeds 185 mm Hg)
Detailed description
Control of blood pressure figures remains one of the most important risk factors in primary and secondary prevention in patients with stroke. The current strategy for the hypertensive treatment of patients during the acute phase of ischemic stroke within the first 72 hours remains a highly debated and unclear issue, with no consensus on the range or appropriate blood pressure ranges to be handled (13).
Team study working hypothesis focuses on the study of blood pressure (for 72 hours), through its intensive control (recording and adjustment every four hours), in the acute phase of ischemic stroke. Specifically, it is based on the monitoring and maintenance of systolic blood pressure between 140 and 160 mm Hg in patients with acute ischemic stroke; And this can lead to a better functional prognosis, measured at 90 days, compared with the functional prognosis of patients treated according to the recommendations of the current Clinical Guidelines, which propose to act on systolic blood pressure only when it exceeds 185 mm Hg (13,22).
Although the intense decrease in blood pressure during the acute phase of stroke has the potential risk of decreasing cerebral perfusion in the area of ischemic penumbra, in recent observational studies (19), a worse functional prognosis has not been found in those patients With systolic blood pressure above 140 mm Hg.
There is no previous evidence from other intervention studies related to blood pressure control and a benefit to patients with acute ischemic stroke. Comparison using a randomized clinical trial of a group of patients with blood pressure control following current guidelines with a group of patients with systolic blood pressure between 140 and 160 mm Hg may allow a simple, rapidly applicable therapeutic alternative to Clinical practice, low cost and extrapolable to a wider population, such as patients with stroke of any etiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National, multicenter, open, two-parallel groups, randomized 1: 1
| Arm | Type | Receives |
|---|---|---|
| Group A: pressure ≥140 and ≤160mmHg | Experimental | Procedure: Group AIntensive management of blood pressure, maintaining a systolic blood pressure ≥ 140 and ≤ 160 mm Hg for 72 hours. |
| Group B: Keep systolic pressure <185mmHg | Active comparator | Procedure: Group BIntensive management of blood pressure, maintaining systolic blood pressure <185 mm Hg for 72 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged 18 years and up to and 85 years (both included).
- Clinical and neuroimaging diagnosis (CT or MRI) of ischemic stroke.
- Possibility of initiating antihypertensive treatment within 12 hours after the onset of symptoms (in the case of stroke, the start time is considered the time in that the patient has been seen asymptomatic for the last time).
- Participant with systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 220 mm Hg at the time of inclusion.
- Participant or legal representative able to understand the study requirements and sign Informed consent.
Key exclusion criteria (20 listed)
- Uncontrollable hypertension (SBP greater than 220 mm Hg) or any condition requiring urgent antihypertensive treatment.
- Have suffered a stroke in the previous 90 days in the same territory as the current stroke.
- Had a myocardial infarction in the previous 90 days.
- Suspected aortic dissection or hypertensive encephalopathy.
- Presence of intracerebral or subarachnoid hemorrhage in basal neuroimaging (Computed tomography or magnetic resonance imaging).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AMaintaining a systolic blood pressure ≥ 140 and ≤ 160mm Hg for 72 hours. | Procedure or surgery | Group A: pressure ≥140 and ≤160mmHg |
| Group BMaintaining a systolic blood pressure <185mm Hg for 72 hours. | Procedure or surgery | Group B: Keep systolic pressure <185mmHg |
Primary outcome
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin
Time frame: 90 days
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin scale measured at 90 ± 15 days will compared between the two branches.Rankin Scale: It is a scale that evaluates the patient's functional situation. The full name is "modified Rankin Scale", and the abbreviated name is "mRS". The range of the scale is from 0 to 6, where 0 is the best score (the patient is asymptomatic) and 6 is the worst score (mortality). Up to 2 the patient is considered independent, and from 3 the patient needs help for the activities of daily life.
5 secondary outcomes
Early Neurological Impairment (ENI)
Time frame: 72 hours
Volume of the infarct in neuroimaging
Time frame: 4th day
Mortality
Time frame: 90 days
Measuring the adverse events
Time frame: 90 days
Volume of the infarct using NIHSS
Time frame: 7th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Rodríguez, MD principal investigator
Hospital Universitario de Santiago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Brain Ischemia, run by Manuel Rodríguez at 3 sites in Spain.
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 5 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Rodríguez, MD (+34981950000, manyanez@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2018.