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Acute Ischemic StrokePhase 4HOPENCT04892511

Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke

A Phase 4 study testing Adjusted medication in people with Acute Ischemic Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mechanical thrombectomy is a very effective treatment in patients who have suffered an acute ischemic stroke associated with intracranial large vessel occlusion. However, less than half of the patients achieve functional independence despite treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Adjusted medication
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
814 participants
Where
1 siteSpain
Study dates
1 Jun 2021to 30 Sep 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with acute ischemic stroke and large intracranial vessel occlusion within 24 hours after the onset of symptoms in whom mechanical thrombectomy has been performed.
  • Successful recanalization, defined as a TICI score of 2b, 2c, or 3.
  • Previous score on the modified Rankin scale (mRS) of 0, 1, or 2.
  • The patient or her legal representative gives informed written or verbal consent

Who cannot join

  • ASPECTS score <6
  • Vertebral, basilar, A2, P2 and M3-4 occlusion
  • History of intracerebral hemorrhage
  • Pregnant or breastfeeding patient
  • Patient with congestive heart failure or recent/unstable coronary artery disease (<3 months)
  • Dissection of aorta, cervical or cerebral or unruptured aortic / cerebral aneurysm or known arteriovenous malformation
Show all 9Show fewer
  • Any bleeding visible on baseline CT
  • History of ventricular arrhythmias
  • Use of MAO inhibitors

Trial locations and contacts

1 site in 1 country.

Joan Martí-Fàbregas, PhD, MD contact

0034 93 5537636

jmarti@santpau.cat

Pol Camps-Renom, PhD, MD contact

0034 935565986

pcamps@santpau.cat

Spain1 site, 1 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Joan Martí-Fàbregas

    Recruiting

Other trials in Spain

About this study

Official title: A Randomized Trial on Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke (HOPE Study)

Mechanical thrombectomy is a very effective treatment in patients who have suffered an acute ischemic stroke associated with intracranial large vessel occlusion. However, less than half of the patients achieve functional independence despite treatment. The optimization of blood pressure after mechanical thrombectomy based on the degree of recanalization achieved at the end of the procedure could improve the perfusion of the ischemic brain tissue thanks to the improvement of blood circulation provided by collateral circulation. For this, authorized hypotensive or hypertensive drugs will be used. Moreover, this individualized treatment would allow to decrease reperfusion injury and therefore decrease the risk of intracerebral bleeding complications and cerebral edema. Therefore, we designed a clinical trial in which the standard management of blood pressure after mechanical thrombectomy will be compared with a specific protocol in which blood pressure targets are applied according to the degree of recanalization obtained during the thrombectomy procedure. The beneficial effect and risk reduction of this treatment will translate into a better short and long-term outcome

Being tested
Adjusted medication
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Adjusted medicationOther

    Also called Labetalol, Urapidil, Phenylephrine, Sodium Nitroprusside

    In patients randomized to perfusion optimization, medication will be adjusted to maintain blood pressure according to the degree of recanalization:

    • Patients with TICI 2b: systolic blood pressure 140-160 mmHg.
    • Patients with TICI 2c-3: systolic blood pressure <140 mmHg.

    Hypotensive drugs will be used when necessary. Intravenous labetalol is the treatment of choice, administered as a bolus or intravenous infusion. Alternative: urapidil (bolus or continuous infusion pump). If both drugs cannot be used or are insufficient, sodium nitroprusside can be used.

    Hypertensive drugs for TICI2b patients whose target pressure is 140-160mmHg and are below this range. Initially, a bolus of physiological saline or 100cc Plasmalyte® will be administered. If this treatment is not effective enough (blood pressure measurements persist <140 mmHg), intravenous phenylephrine will be administered.

Study groups in NCT04892511
Study groupRoleWhat they receive
Standard treatmentNo interventionPost-thrombectomy patients will have their blood pressure measured every hour for the first 24 hours after thrombectomy, and every 6 hours from 24 to 72 hours. The target blood pressure is not predefined by the study, but in patients who have received previous treatment with rt-PA, it is advisable to keep it below 180/110 mmHg. If the patient has not received rt-PA, there is no limitation, although the guidelines recommend keeping the pressure below 200/120 mmHg. The hypotensive or hypertensive treatments used will be noted.
Optimized hemodynamic treatmentExperimentalPost-thrombectomy patients will have their blood pressure measured every 30 minutes for the first 24 hours after thrombectomy, and every 1 hour from 24 to 72 hours. Blood pressure objectives will depend on the degree of recanalization achieved after thrombectomy (see intervention section). The hypotensive or hypertensive treatments used will be noted.
Receives: Other: Adjusted medication

What is being measured

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

  1. Modified Rankin scale value

    State of functional independence, measured with the modified Rankin scale at 3 months (+/- 14 days).

    Measured: 3 months

Secondary outcomes (8)

  1. NIHSS score

    Measured: 24 hours

  2. Mortality

    Mortality from any cause at 3 months post-thrombectomy

    Measured: 3 months

  3. Intracranial hemorrhagic complication

    Rate of any intracranial hemorrhagic complication in the first 24 hours after the procedure.

    Measured: 24 hours

  4. Intracranial hemorrhagic complication

    Rate of any intracranial hemorrhagic complication in the first 72 hours after the procedure.

    Measured: 72 hours

  5. Cerebral edema

    Volume of cerebral edema at 24 hours in the post-thrombectomy CT scan.

    Measured: 24 hours

  6. Cerebral edema

    Volume of cerebral edema at 72 hours in the post-thrombectomy CT scan.

    Measured: 72 hours

  7. Infarct size in the 24-hour post-thrombectomy CT.

    Infarct size in the 24-hour post-thrombectomy CT.

    Measured: 24 hours

  8. Infarct size in the 72-hour post-thrombectomy CT.

    Infarct size in the 72-hour post-thrombectomy CT.

    Measured: 72 hours

Timeline

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

  1. First posted19 May 2021
  2. Study start1 Jun 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
814 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892511
Sponsor's protocol ID
IIBSP-HOP-2021-01
Acronym
HOPE
Status last verified
Mar 2023
First submitted
14 May 2021
Last updated
16 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Camps-Renom P, Guasch-Jimenez M, Alvarez-Cienfuegos J, Lopez-Hernandez N, Rodriguez-Campello A, Tejada-Meza H, Lopez-Mesonero L, Albert-Lacal L, Freijo-Guerrero MM, Tarruella-Hernandez D, Flores A, Cabezas-Rodriguez JA, Fernandez-Vidal JM, Martinez-Domeno A, Perez de la Ossa N, Ramos-Pachon A, Aguilera-Simon A, Marin R, Ezcurra-Diaz G, Lambea-Gil A, Silva Y, Corona-Garcia DJ, Giralt-Steinhauer E, Marta-Moreno J, Vizcaya-Gaona JA, Sanz-Monllor A, Luna A, Lopez Morales M, Ustrell X, Moniche F, Sola-Roca J, Wang X, Anderson CS, Prats-Sanchez L, Marti-Fabregas J; HOPE Study Group. Personalized Blood Pressure Targeting After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2026 Aug 1;83(8):788-797. doi: 10.1001/jamaneurol.2026.1706.

    PubMed 42258192

  • Camps-Renom P, Guasch-Jimenez M, Martinez-Domeno A, Prats-Sanchez L, Ramos-Pachon A, Alvarez-Cienfuegos J, Silva Y, Fortea-Cabo G, Morales-Caba L, Rodriguez-Campello A, Giralt-Steinhauer E, Flores A, Ustrell X, Lopez-Hernandez N, Corona-Garcia DJ, Freijo-Guerrero MM, Luna A, Tejada-Meza H, Marta-Moreno J, Moniche F, Pardo-Galiana B, Castellanos M, Albert-Lacal L, Sanz-Monllor A, Aguilera-Simon A, Marin R, Ezcurra-Diaz G, Lambea-Gil A, Marti-Fabregas J. A Randomized Trial on Hemodynamic Optimization of Cerebral Perfusion after Successful Endovascular Therapy in Patients with Acute Ischemic Stroke (HOPE). Cerebrovasc Dis. 2025;54(4):559-566. doi: 10.1159/000540606. Epub 2024 Aug 29.

    PubMed 39208776

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adjusted medication in people with Acute Ischemic Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site 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 4 inclusion and 9 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 16 Mar 2023. 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 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.

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?

Results are not available in the source record.

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

Contact Joan Martí-Fàbregas, PhD, MD (0034 93 5537636, jmarti@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin scale value (time frame: 3 months). 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 NCT04892511, which also lists 2 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 16 Mar 2023.

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