Overview
Sponsor-declared trial summary
Acute Ischemic Stroke
Compare the clinical benefit of standard blood pressure management after mechanical thrombectomy versus a specific protocol aimed at hemodynamic optimization, where blood pressure targets are applied based on the degree of recanalization achieved during the procedure. Compare the clinical benefit of standard blood p…
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 16 Jun 2021 → 15 Jan 2026
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516642-19-01
- EudraCT number
- 2021-000022-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Compare the clinical benefit of standard blood pressure management after mechanical thrombectomy versus a specific protocol aimed at hemodynamic optimization, where blood pressure targets are applied based on the degree of recanalization achieved during the procedure.
Compare the clinical benefit of standard blood pressure management after mechanical thrombectomy versus a specific protocol aimed at hemodynamic optimization, where blood pressure targets are applied based on the degree of recanalization achieved during the procedure.
Conditions and MedDRA coding
Acute Ischemic Stroke
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516642-19-00 | A randomized trial on Hemodynamic Optimization of cerebral Perfusion after Endovascular therapy in patients with acute ischemic stroke (HOPE study) | Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients with acute ischemic stroke and large intracranial vessel occlusion within 24 hours of symptom onset who have undergone mechanical thrombectomy.
- Successful recanalization, defined as a TICI score of 2b, 2c, or 3.
- Prior score on the modified Rankin Scale (mRS) of 0, 1, or 2.
- The patient or their legal representative provides informed consent in writing or verbally.
Exclusion criteria 10
- ASPECTS score < 6
- Occlusion in the vertebral, basilar, A2, P2, and M3-4 arteries.
- History of intracerebral hemorrhage
- Pregnant or lactating patient
- Patient with congestive heart failure or unstable or recent coronary artery disease (<3 months)
- Dissection of the aorta, cervical, or cerebral arteries, or unruptured aortic/cerebral aneurysm or known arteriovenous malformation
- Any visible hemorrhage on the initial CT scan
- History of ventricular arrhythmias
- Use of MAO inhibitors
- Inclusion in other clinical trials.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Direct comparison between the two arms of the trial with respect to mRS score at 90 days after randomization. This will be an intention to treat analysis. The main effect parameter will be the OR of change (shift analysis) in the direction of a better result in the mRS with its 95% confidence interval.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Urapidil Accord 5 mg/ml solución inyectable y para perfusión EFG
PRD2919310 · Product
- Active substance
- Urapidil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/ml milligram(s)/millilitre
- Max total dose
- 5 mg/ml milligram(s)/millilitre
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- C02CA06 — URAPIDIL
- Marketing authorisation
- 76741
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fenilefrina Altan 0,1 mg/ml solución inyectable y para perfusión.
PRD8140061 · Product
- Active substance
- Phenylephrine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 µg/Kg microgram(s)/kilogram
- Max total dose
- 100 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA06 — PHENYLEPHRINE
- Marketing authorisation
- 84988
- MA holder
- ALTAN PHARMACEUTICALS S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trandate 5mg/ml Solution for Injection
PRD2429245 · Product
- Active substance
- Labetalol Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.8 mg/l milligram(s)/litre
- Max total dose
- 0.8 mg/l milligram(s)/litre
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AG01 — LABETALOL
- Marketing authorisation
- PA 1638/6/1
- MA holder
- RPH PHARMACEUTICALS AB
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 814 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2021-06-16 | 2026-01-15 | 2021-06-16 | 2025-09-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo 2021-000022-10 for pub | 5 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PUB | 3 |
| Synopsis of the protocol (for publication) | D1_Protocolo Synopsis IIBSP-HOP-2021-01 V5_sp PUB | 5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-05 | Spain | Acceptable 2024-11-11
|
2024-11-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-13 | Spain | Acceptable 2025-06-30
|
2025-07-07 |