EuroHYP-1: European phase III clinical trial at multiple trial sites and with random allocation of patients to treatment groups. The trial compares whole body cooling plus best medical treatment to best medical treatment alone in patients with acute stroke.

Phase 1

Active, not recruiting

• Conditions: Acute Ischaemic Stroke; MedDRA version: 19.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002944-25-IE
• Lead Sponsor: St James's Hospital, Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-10
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

The trial population consists of patients of both sexes, aged =18 years, with acute ischaemic stroke and a score on the NIHSS of =6 at screening [Assessment 1, within 90 minutes before the start of the treatment phase TP].
- Written informed consent obtained from the patient or his/her legally acceptable representative or under such other arrangements as may be legally established in participating countries.
- Estimated body weight of 50kg up to and including 120kg.
- Possibility to start therapeutic hypothermia within 6 hours after onset of stroke.
- Possibility to start therapeutic hypothermia within 150 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site or within 150 minutes after start of endovascular treatment, if this is later.
- Possibility to start therapeutic hypothermia within 90 minutes after admission to trial site in patients not receiving thrombolysis or in patients who have received thrombolysis at a different site.
- mRS score =2 prior to onset of stroke.
- GCS motor response subscale score =5.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

Exclusion Criteria

1.Current use of medication interacting with pethidine or buspirone.
2. Use of monoaminoxidase inhibitors in the 14 days prior to screening. 3. Acute alcohol intoxication.
4. Opioid addiction.
5. Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential.
6. Known hypersensitivity to the IMPs or any of their formulation ingredients.
7. Patient who is imprisoned or is lawfully kept in an institution.
8. Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor.
9. Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial.
10. Prior participation in this trial.
11. Any acutely life-threatening conditions other than acute ischaemic stroke.
12. Rapidly resolving stroke symptoms.
13. Evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis or any diagnosis likely to cause the present symptoms other than acute ischaemic stroke.
14. Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis.
15. SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration.
16. Other severe respiratory disorder.
17. Bradycardia (<40 bpm).
18. Severe cardiac failure, defined as NYHA classification =III.
19. Myocardial infarction or angina pectoris in the 3 months prior to screening.
20. Vasospastic disorders.
21. Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia).
22. Known platelet count <100,000/mm3.
23. Known INR >1.7.
24. Skin damage at the sites intended to be used for cooling.
25. Clinical diagnosis of sepsis.
26. Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN).
27. Known renal impairment (serum creatinine >2mg/100ml).
28. Addison's disease.
29. Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia.
30. Any condition that is thought to reduce the compliance to cooperate with the trial procedures .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified