A Randomized Trial on Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke (HOPE Study)
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 814
- Locations
- 1
- Primary Endpoint
- Modified Rankin scale value
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Previous score on the modified Rankin scale (mRS) of 0, 1, or
- •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.
Outcomes
Primary Outcomes
Modified Rankin scale value
Time Frame: 3 months
State of functional independence, measured with the modified Rankin scale at 3 months (+/- 14 days).
Secondary Outcomes
- Mortality(3 months)
- Intracranial hemorrhagic complication(72 hours)
- Infarct size in the 24-hour post-thrombectomy CT.(24 hours)
- NIHSS score(24 hours)
- Infarct size in the 72-hour post-thrombectomy CT.(72 hours)
- Cerebral edema(72 hours)