Clinical trial NCT04892511: Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke
Official title: A Randomized Trial on Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke (HOPE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Any bleeding visible on baseline CT
* History of ventricular arrhythmias
* Use of MAO inhibitors
* Inclusion in other clinical trials.

Primary outcomes:
measure: Modified Rankin scale value
timeFrame: 3 months
Secondary outcomes:
measure: NIHSS score
timeFrame: 24 hours
measure: Mortality
timeFrame: 3 months
measure: Intracranial hemorrhagic complication
timeFrame: 24 hours
measure: Intracranial hemorrhagic complication
timeFrame: 72 hours
measure: Cerebral edema
timeFrame: 24 hours
measure: Cerebral edema
timeFrame: 72 hours
measure: Infarct size in the 24-hour post-thrombectomy CT.
timeFrame: 24 hours
measure: Infarct size in the 72-hour post-thrombectomy CT.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: