NCT06059144RecruitingPhase 3
Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine
Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
PRESSURE is a multicenter, prospective, randomized, open, blinded end-point assessed (PROBE) trial, that aims to evaluate the efficacy and safety of drug-induced hypertension using peripheral dilute norepinephrine, in patients with acute ischemic stroke in a perforating artery territory and experiencing early neurological deterioration.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 358 (estimated)
- First submitted
- 26 May 2023
- Start date
- 28 Nov 2024
- Primary completion date
- 28 Aug 2027
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Stroke, High blood pressure
- NCT number
- NCT06059144
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 358
- From 28 Nov 2024 to the primary completion date, 28 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- High risk of intracerebral hemorrhage:
- Cerebral microbleeds ≥ 10
- Non traumatic focal superficial siderosis
- Hemorrhagic transformation of the present ischemic stroke
- Previous history of intracerebral hemorrhage (symptomatic or asymptomatic identified on brain MRI)
- Intracranial vascular malformation or tumor with suspected risk of rupture or bleeding
- Prior intravenous thrombolysis \< 24 hours
- Drugs with important interactions with norepinephrine: monoamine oxidase inhibitors (including reversible, non-selective agents such as linezolid), tricyclic antidepressants, entacapone.
Other illness
- \- Pre-Stroke Modified Rankin Score \> 3
- Large artery atherosclerosis (ipsilateral atherosclerotic stenosis \> 50%), intra and extracranial dissection, or cardio-embolic stroke mechanisms
Other
- Contraindication to brain Magnetic Resonance Imaging (MRI)
- Requirement for anticoagulation in the first 7 days after randomization
- Systolic blood pressure (SBP) \> 180mmHG and/or mean arterial pressure (MAP) ≥ 110mmHG at inclusion
- Pregnancy or breastfeeding
Who the study is looking for
- Acute ischemic stroke \< 72 h in a perforating artery territory on brain MRI
- Early neurological deterioration or fluctuation, attested by the neurologist in charge, defined by a ≥ 3-point increase in global NIHSS score OR a 2-point increase on motor or ataxia score, whether this deterioration is transient or permanent.
- Time between early neurological deterioration and randomization \< 6 hours
- Age ≥ 18 years
- Contraception required in women of childbearing potential (Intra-uterine device, hormonal contraception associated with inhibition of ovulation (combined or progestogen-only; oral, intravaginal or transdermal), Female Sterilization, Vasectomised partner, sexual abstinence)
- Beneficiary of a health insurance system
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.