Actively Recruiting
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Led by DiaMedica Therapeutics Inc · Updated on 2026-04-28
728
Participants Needed
66
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.
CONDITIONS
Official Title
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years inclusive
- Weight between 40 kg and 166 kg inclusive
- Treatment started within 24 hours of stroke onset
- NIH Stroke Scale score of 5 to 15 at randomization or after clinical worsening
- Pre-stroke modified Rankin Scale score of 0 to 1
- If received fibrinolytics within 4.5 hours, persistent moderate neurological deficit at least 6 hours after treatment
- Ability to provide informed consent
- Willingness and ability to follow study procedures as judged by investigator
You will not qualify if you...
- Hemorrhagic stroke confirmed by imaging
- Large vessel occlusion in specific brain arteries
- Large established brain infarction (ASPECTS 0-5)
- Planned or received mechanical thrombectomy for current stroke
- Suspected or confirmed extracranial arterial dissection
- Brain stem or cerebellar stroke involvement (except posterior cerebral artery alone)
- Low blood pressure (SBP <100 mmHg or MAP <65 mmHg) before randomization
- Current use of ACE inhibitors without ability to switch medications
- ACE inhibitor taken less than 24 hours before study drug infusion
- History of severe allergic reactions requiring hospitalization
- Diagnosis or suspicion of hereditary angioedema or related treatments
- Life expectancy less than 1 year
- Active infection requiring intravenous treatment or hospitalization
- Known alpha 1-antitrypsin deficiency
- Pregnancy or nursing (unless nursing is stopped per investigator discretion)
- Childbearing potential without agreeing to use effective contraception and negative pregnancy test
- Participation in another investigational drug/device study within 30 days
- Insufficient venous access for treatment or sampling
- Inability or unwillingness to comply with study requirements
- Any medical condition making participation unsafe or interfering with results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 66 locations
1
Gulf Health Hospitals d/b/a Thomas Hospital
Fairhope, Alabama, United States, 36532
Actively Recruiting
2
USC Arcadia Hospital
Arcadia, California, United States, 91007
Actively Recruiting
3
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Glendale, California, United States, 91206-4152
Actively Recruiting
4
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027-5209
Actively Recruiting
5
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
6
Stanford Health Care
Stanford, California, United States, 94305
Actively Recruiting
7
The Lundquist Institute at Harbor UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
8
Memorialcare Long Beach Medical Center
Torrance, California, United States, 90806
Actively Recruiting
9
HCA Florida - JFK Medical Center
Atlantis, Florida, United States, 33462-1149
Actively Recruiting
10
Boca Raton Regional Hospital Marcus Neuroscience Institute
Boca Raton, Florida, United States, 33486
Actively Recruiting
11
Holy Cross Health
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
12
University of Florida Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
13
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239-2617
Actively Recruiting
14
Tampa General Hospital (TGH) - The Stroke Center
Tampa, Florida, United States, 33606-3603
Actively Recruiting
15
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
16
Ascension Via Christi Hospitals Wichita Inc.
Wichita, Kansas, United States, 67214
Actively Recruiting
17
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
18
UMASS Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
19
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
20
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
21
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
22
The University of New Mexico - School of Medicine
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
23
Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York, United States, 10075
Actively Recruiting
24
Summa Health Clinical Research Center
Akron, Ohio, United States, 44304
Actively Recruiting
25
The Clinical Neuroscience Institute
Dayton, Ohio, United States, 45431
Active, Not Recruiting
26
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Actively Recruiting
27
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
28
Ascension St. John
Tulsa, Oklahoma, United States, 74104
Active, Not Recruiting
29
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
30
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
31
Prisma Health-Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
32
Erlanger Hospital
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
33
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States, 37404-1163
Actively Recruiting
34
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Actively Recruiting
35
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
36
Imeldaziekenhuis (Imelda Hospital)
Bonheiden, Belgium, Belgium, 015 50 50 11
Actively Recruiting
37
UZ Gent
Ghent, Belgium, Belgium, 9000
Actively Recruiting
38
Jessa Ziekenhuis
Hasselt, Belgium, Belgium, 3500
Actively Recruiting
39
AZ Groeninge
Kortrijk, Belgium, Belgium, 8500
Actively Recruiting
40
Clinique St Pierre
Ottignies, Belgium, Belgium, 1340
Actively Recruiting
41
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2G3 7802481660
Actively Recruiting
42
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Actively Recruiting
43
Health Sciences North
Hamilton, Ontario, Canada, L8L2X2
Actively Recruiting
44
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L8E7
Actively Recruiting
45
Sunnybrook Research Institute
North York, Ontario, Canada, M4N 3M5
Actively Recruiting
46
CHU Pontchaillou /Hopital Sud Service de Neurologie
Rennes, Brittany Region, France, 35033
Actively Recruiting
47
West Georgia Medical Center LTD
Kutaisi, Georgia, Georgia, 4600
Actively Recruiting
48
Israel-Georgia Medical Research Clinic-Healthycore LTD
Tbilisi, Georgia, Georgia, 0112
Actively Recruiting
49
New Hospitals LTD
Tbilisi, Georgia, Georgia, 0114
Actively Recruiting
50
Pineo Medical Ecosystem LTD
Tbilisi, Georgia, Georgia, 0114
Actively Recruiting
51
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia, Georgia, 0159
Actively Recruiting
52
Bajcsy-Zsilinszky Hospital
Budapest, Hungary, Hungary, 1106
Actively Recruiting
53
St. Damjan Greek Catholic Hospital
Kisvárda, Hungary, Hungary, 4600
Actively Recruiting
54
B.-A.-Z. County Central Hospital
Miskolc, Hungary, Hungary, 3526
Actively Recruiting
55
Petz Aladár County Teaching Hospital
Győr, Vasvári Pál U. 2-4, Hungary, 9024
Actively Recruiting
56
Fundeni Clinical Institute
Bucharest, Bucharest (Sector 2), Romania, 022328
Actively Recruiting
57
Elias Emergency University Hospital
Bucharest, Romania, Romania, 011461
Actively Recruiting
58
Instituto de Investigacion Biomedica de A Coruna (INIBIC)
A Coruña, Spain, Spain, 15006
Actively Recruiting
59
Hospital Universitario Germans Trias i Pujol
Badalona, Spain, Spain, 8916
Actively Recruiting
60
Hospital Universitari Vall d'Hebron-Institut de Recerca
Barcelona, Spain, Spain, 8035
Actively Recruiting
61
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain, Spain, 15706
Actively Recruiting
62
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom, EX25DW
Actively Recruiting
63
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
Newcastle upon Tyne, England, United Kingdom, NE1 4LP
Actively Recruiting
64
Addenbrooke's Hospital
Cambridge, United Kingdom, United Kingdom, CB2 0QQ
Actively Recruiting
65
St George's Hospital
London, United Kingdom, United Kingdom, SW17 0QT
Actively Recruiting
66
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
K
Kayla Slupek
CONTACT
A
Adrienne Ford
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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