Dual Thrombolytic Therapy With Mutant Pro-urokinase and Low Dose Alteplase for Ischemic Stroke (DUMAS)
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|ClinicalTrials.gov Identifier: NCT04256473|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: mutant pro-urokinase Drug: Alteplase||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Dual Thrombolytic Therapy With Mutant Pro-urokinase (M-pro-urokinase, HisproUK) and Low Dose Alteplase for Ischemic Stroke|
|Actual Study Start Date :||August 10, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Bolus of IV alteplase (5 mg) followed by continuous infusion of HisproUK 40 mg/hr during 60 minutes.
Depending on results of interim analyses, the alternate dose may be revised to a lower dose (30mg/hr during 60 minutes) or a higher dose (50mg/hr during 60 minutes).
Drug: mutant pro-urokinase
Other Name: HisproUK
Active Comparator: Control
Usual care with alteplase 0.9 mg/kg in 60 minutes
Other Name: Actilyse
- Any intracranial hemorrhage according to the Heidelberg Bleeding Classification on MRI [ Time Frame: 24-48 hours post-treatment ]
- Score on the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: at 24 hours and 5-7 days post-treatment ]The NIHSS measures neurological deficit, ranging from 0 to 42, with higher scores indicating more severe neurological deficit.
- Score on the modified Rankin Scale (mRS) [ Time Frame: at 30 days ]The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death) measuring the degree of disability or dependence in everyday life.
- Infarct volume on MRI [ Time Frame: at 24-48 hours ]
- Change (pre-treatment vs. post-treatment) in abnormal perfusion volume based on TTP/MTT maps measured with CT perfusion at baseline and MRI [ Time Frame: at 24-48 hours post treatment. ]
- Secondary blood biomarkers of thrombolysis: d-dimer levels and fibrinogen levels. [ Time Frame: 1 hour post-treatment, after 3 hours, and after 24 hours post-treatment, ]
- Symptomatic intracranial hemorrhage (sICH) according to the Heidelberg Bleeding Classification [ Time Frame: within 30 days ]sICH is defined as any intracranial hemorrhage followed by a neurological deterioration that can be attributed to that hemorrhage, defined as an increase of >= 4 points on the NIHSS or >= 2 points on a specific NIHSS item.
- Death from any cause [ Time Frame: Within 30 days ]
- Major extracranial hemorrhage according to the ISTH criteria [ Time Frame: within 24 hours of study drug administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256473
|DUMAS trial office||Recruiting|
|Rotterdam, Netherlands, 3000 CA|
|Contact: DUMAS trial office 0639583967 ext 0639583967 email@example.com|
|Principal Investigator: Diederik WJ Dippel, MD, PhD|