Clinical Trials List
Protocol Number12402A
2008-12-01 - 2011-11-30
Phase III
Terminated6
ICD-10I67.81
Acute cerebrovascular insufficiency
ICD-10I67.82
Cerebral ischemia
ICD-10I67.89
Other cerebrovascular disease
ICD-9437.1
Other generalized ischemic cerebrovascular disease
A randomised, double-blind, parallel-group placebo-controlled phase Ill study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke
-
Trial Applicant
STATPLUS, INC.
-
Sponsor
H. Lundbeck A/S
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 鍾芷萍 Division of Neurology
- 陳世彬 Division of Neurology
- 翁文章 Division of Neurology
- 鄧木火 Division of Radiology
- 陳世彬 Division of Neurology
- 李怡慧 Division of Neurology
- Yi-Chun Lee Division of Neurology
- 許立奇 Division of Neurology
- Chang-Ming Chern Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Te-Fa Chiu Division of Emergency Medicine
- 張寓智 Division of Neurology
- 羅祥雲 Division of Neurology
- 黃浩輝 Division of Radiology
- Yu-Jhih Chang Division of Neurology
- 張健宏 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wei-Shih Huang Division of Neurology
- 蔡宗璋 Division of Neurology
- Kang-Hsu Lin Division of Neurology
- 曾鈞宏 Division of Neurology
- 陳維恭 Division of Emergency Medicine
- 呂宗達 Division of Neurology
- 楊明祥 Division of Radiology
- Woei-Cheang Shyu Division of Neurology
- 陳泰逸 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林威辰 Division of Radiology
- 黃柏穎 Division of Neurology
- 許錦田 Division of Neurology
- Chien Fu Chen Division of Neurology
- chunhung chen Division of Neurology
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
CRO
Co-Principal Investigator
- 謝函潔 Division of Neurology
- Chih-Hung Chen Division of Neurology
- 謝鎮陽 Division of Neurology
- 莊明宗 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Ischemic stroke
Objectives
Use the good results on the 90th day to evaluate the efficacy of 90 μg/kg Desmoteplas compared with placebo for subjects with acute ischemic stroke
Test Drug
Desmoteplase
Active Ingredient
Desmoteplase
Dosage Form
A vial containing lyophilised powder for solution for injection
Dosage
90mg/kg
Endpoints
*Efficacy
a) Main variables: The Modified Rankin Scale (mRS) on the 90th day will be used as the main efficacy variable
b) Secondary variable: National Institutes of Health Stroke Scale (NIHSS)
c) Other variables: the effect of vascular re-opening in the 12th to 24th hours (sub-test)
*Pharmacokinetics/Pharmacodynamics
Within 0.5 to 9 hours after the administration of IMP, two blood samples will be collected (at least 2 hours apart) for pharmacokinetic and pharmacodynamic analysis of the test population
*safety
1. Mortality
2. Incidence of symptomatic intracranial hemorrhage (sICH)
3. Incidence of major bleeding complications other than sICH
4. Incidence of symptomatic ischemic edema
5. Incidence of asymptomatic intracranial hemorrhage (aICH)
6. Adverse events, clinical safety laboratory testing, vital signs, electrocardiogram, physical examination
*Pharmaceutical Economics
1. Short Form-36(SF-36)
2. Health Questionnaire (EuroQol)
3. Resource Utilisation
a) Main variables: The Modified Rankin Scale (mRS) on the 90th day will be used as the main efficacy variable
b) Secondary variable: National Institutes of Health Stroke Scale (NIHSS)
c) Other variables: the effect of vascular re-opening in the 12th to 24th hours (sub-test)
*Pharmacokinetics/Pharmacodynamics
Within 0.5 to 9 hours after the administration of IMP, two blood samples will be collected (at least 2 hours apart) for pharmacokinetic and pharmacodynamic analysis of the test population
*safety
1. Mortality
2. Incidence of symptomatic intracranial hemorrhage (sICH)
3. Incidence of major bleeding complications other than sICH
4. Incidence of symptomatic ischemic edema
5. Incidence of asymptomatic intracranial hemorrhage (aICH)
6. Adverse events, clinical safety laboratory testing, vital signs, electrocardiogram, physical examination
*Pharmaceutical Economics
1. Short Form-36(SF-36)
2. Health Questionnaire (EuroQol)
3. Resource Utilisation
Inclution Criteria
Inclusion conditions:
Any subject who meets all of the following conditions is eligible for inclusion in this trial:
1. Clinically diagnosed as acute ischemic stroke
2. Comply with the procedures approved by the human test committee responsible for approving this test by the test center, and obtain the consent form of the subject
3. Men or women aged 18 to 85 (inclusive)
4. Subjects who can start treatment within 3 to 9 hours after the onset of stroke symptoms. If the actual onset time of the stroke is not known, the last time when the subject is still healthy is regarded as the onset time. For subjects who are suitable for Alteplase treatment, all examinations should be performed, and Alteplase treatment should be administered within 3 hours of the onset of symptoms to avoid delays
5. The NIHSS score is 4 to 24 points (inclusive), and subjects with cerebral infarction, such as hemiplegia
6. Subjects should receive the experimental drug (IMP) within 60 minutes after completing the diagnostic contrast scan
Inclusion conditions for diagnostic imaging scans:
7. Evaluate the proximal cerebral artery associated with acute clinical blood insufficiency by MRA or CTA, and found occlusion or high stenosis in the subject. The above-mentioned eligible blood vessels include middle cerebral artery MCA M1, MCA M2, anterior cerebral artery (ACA) or posterior cerebral artery (PCA).
Any subject who meets all of the following conditions is eligible for inclusion in this trial:
1. Clinically diagnosed as acute ischemic stroke
2. Comply with the procedures approved by the human test committee responsible for approving this test by the test center, and obtain the consent form of the subject
3. Men or women aged 18 to 85 (inclusive)
4. Subjects who can start treatment within 3 to 9 hours after the onset of stroke symptoms. If the actual onset time of the stroke is not known, the last time when the subject is still healthy is regarded as the onset time. For subjects who are suitable for Alteplase treatment, all examinations should be performed, and Alteplase treatment should be administered within 3 hours of the onset of symptoms to avoid delays
5. The NIHSS score is 4 to 24 points (inclusive), and subjects with cerebral infarction, such as hemiplegia
6. Subjects should receive the experimental drug (IMP) within 60 minutes after completing the diagnostic contrast scan
Inclusion conditions for diagnostic imaging scans:
7. Evaluate the proximal cerebral artery associated with acute clinical blood insufficiency by MRA or CTA, and found occlusion or high stenosis in the subject. The above-mentioned eligible blood vessels include middle cerebral artery MCA M1, MCA M2, anterior cerebral artery (ACA) or posterior cerebral artery (PCA).
Exclusion Criteria
Exclude conditions:
Any subject who meets one or more of the following conditions will not be included in this trial:
1. The subject's mRS score before stroke is> 1, which means that the subject has been disabled in the past
2. The subject has used desmoteplase in the past
3. The subject has participated in any research trial in the past 30 days
4. The subject has terminal illness and the life expectancy is less than 6 months
5. Judging by the trial host, if the trial therapy is performed, the subject’s disease will cause harm to the subject or affect the subject’s participation in the trial (for example, the subject has metastatic cancer or severe microvascular disease, (Such as hemolytic uremic disease or thrombotic thrombocytopenic purpura)
6. In NIHSS, the level of awareness of question 1a is> 2
7. Subjects with a history or clinical manifestations of intracranial hemorrhage, subarachnoid hemorrhage (SAH), arteriovenous malformation, aneurysm or brain tumor. Subjects with occasional small intracranial aneurysms, if the aneurysm is less than 5mm, does not form a thrombus, and the bleeding is not visible to the naked eye, it may be considered for inclusion in the study
8. Subject has symptomatic acute vertebral artery or basilar artery occlusion
9. The subject used oral anticoagulants and caused the prolongation of the original time of clotting (INR> 1.6)
10. The subject has been treated with heparin in the past 48 hours, and has caused partial blood clotting to prolong the time and exceed the upper limit of the normal range of the local laboratory. Prophylactic use of low-dose LMWH (for example: deep vein thrombosis (DVT) prevention) does not disqualify subjects from participating in the trial.
11. The subject has received glycoprotein IIb-IIIa inhibitors in the past 72 hours. Before entering the trial, subjects may be allowed to use a single dose of oral platelet inhibitor (clopidogrel 75 mg or low-dose aspirin <325 mg) or a combination of low-dose aspirin (50 mg) and dipyridamole (400 mg )
12. The subject has received factor Xa inhibitors in the past 72 hours
13. The subject's basal platelet count <100,000/ mm³
14. The subject's basal blood volume <0.25
15. The subject's basal blood glucose <50 mg/dl or> 200 mg/dl (< 3 mmol/l or> 11 mmol/l). Subjects with a blood glucose level between 200 and 300 mg/dl can only be considered for inclusion in the trial if the blood glucose level drops to <200 mg/dl after antidiabetic drug treatment and before the use of the trial drug
16. The subject suffers from uncontrolled hypertension, defined as systolic blood pressure> 185 mmHg or diastolic blood pressure> 110 mmHg in at least two examinations (at least 10 minutes apart), or requires aggressive treatment to reduce blood pressure to normal Within the upper limit. Aggressive treatment is defined at the discretion of the test host
17. The subject suffers from hereditary or acquired hemorrhagic constitution
18. The subject has had gastrointestinal or urethral bleeding in the past 21 days
19. The subject has had an arterial puncture in an incompressible area in the past 7 days
20. The subject has had another stroke or serious head injury in the past 6 weeks
21. The subject has undergone major surgery in the past 14 days
22. The subject has epilepsy while having a stroke
23. The subject has had an acute myocardial infarction (AMI) in the past 3 weeks
24. The subject has received thrombolytic therapy in the past 72 hours
25. The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically confirmed pregnancy)
26. As judged by the trial host, the subject may not be able to cooperate with the clinical trial plan or be unsuitable to join for any other reason
Exclusion conditions for diagnostic imaging scans:
27. The subject has extensive early infarction in any affected part of MRI or CT, that is, the core of the infarct occupies> 1/3 of the MCA area or> 1/2 of the ACA or PCA area
28. Subjects with angiographic evidence of ICH or SAH (regardless of the age at which bleeding occurred); arteriovenous malformations; cerebral aneurysms; or brain tumors (incidental meningioma and microleakage are not excluded. Small size (< 5) (Mm) Occasional intracranial aneurysm, no thrombosis, and bleeding is not visible to the naked eye, it is not an exclusionary condition)
29. The subject has confirmed parenchymal hyperintensity on FLAIR, T2* or EPI-T2 angiography, or the obvious low density on CT indicates subacute cerebral infarction, or the intensity of the pattern characteristics indicates that the lesion has more than 9 hours
30. The subject has an internal carotid artery occlusion on the side of the stroke lesion
31. The subject has contraindications to contrast technology (ie, strong magnetic objects of MRI, contraindications to contrast agents, etc.. Please refer to the contraindications of contrast technology in the contrast manual)
32. The subject has any intracranial lesions that will interfere with the evaluation of the imaging technique used to perform the scan.
Any subject who meets one or more of the following conditions will not be included in this trial:
1. The subject's mRS score before stroke is> 1, which means that the subject has been disabled in the past
2. The subject has used desmoteplase in the past
3. The subject has participated in any research trial in the past 30 days
4. The subject has terminal illness and the life expectancy is less than 6 months
5. Judging by the trial host, if the trial therapy is performed, the subject’s disease will cause harm to the subject or affect the subject’s participation in the trial (for example, the subject has metastatic cancer or severe microvascular disease, (Such as hemolytic uremic disease or thrombotic thrombocytopenic purpura)
6. In NIHSS, the level of awareness of question 1a is> 2
7. Subjects with a history or clinical manifestations of intracranial hemorrhage, subarachnoid hemorrhage (SAH), arteriovenous malformation, aneurysm or brain tumor. Subjects with occasional small intracranial aneurysms, if the aneurysm is less than 5mm, does not form a thrombus, and the bleeding is not visible to the naked eye, it may be considered for inclusion in the study
8. Subject has symptomatic acute vertebral artery or basilar artery occlusion
9. The subject used oral anticoagulants and caused the prolongation of the original time of clotting (INR> 1.6)
10. The subject has been treated with heparin in the past 48 hours, and has caused partial blood clotting to prolong the time and exceed the upper limit of the normal range of the local laboratory. Prophylactic use of low-dose LMWH (for example: deep vein thrombosis (DVT) prevention) does not disqualify subjects from participating in the trial.
11. The subject has received glycoprotein IIb-IIIa inhibitors in the past 72 hours. Before entering the trial, subjects may be allowed to use a single dose of oral platelet inhibitor (clopidogrel 75 mg or low-dose aspirin <325 mg) or a combination of low-dose aspirin (50 mg) and dipyridamole (400 mg )
12. The subject has received factor Xa inhibitors in the past 72 hours
13. The subject's basal platelet count <100,000/ mm³
14. The subject's basal blood volume <0.25
15. The subject's basal blood glucose <50 mg/dl or> 200 mg/dl (< 3 mmol/l or> 11 mmol/l). Subjects with a blood glucose level between 200 and 300 mg/dl can only be considered for inclusion in the trial if the blood glucose level drops to <200 mg/dl after antidiabetic drug treatment and before the use of the trial drug
16. The subject suffers from uncontrolled hypertension, defined as systolic blood pressure> 185 mmHg or diastolic blood pressure> 110 mmHg in at least two examinations (at least 10 minutes apart), or requires aggressive treatment to reduce blood pressure to normal Within the upper limit. Aggressive treatment is defined at the discretion of the test host
17. The subject suffers from hereditary or acquired hemorrhagic constitution
18. The subject has had gastrointestinal or urethral bleeding in the past 21 days
19. The subject has had an arterial puncture in an incompressible area in the past 7 days
20. The subject has had another stroke or serious head injury in the past 6 weeks
21. The subject has undergone major surgery in the past 14 days
22. The subject has epilepsy while having a stroke
23. The subject has had an acute myocardial infarction (AMI) in the past 3 weeks
24. The subject has received thrombolytic therapy in the past 72 hours
25. The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically confirmed pregnancy)
26. As judged by the trial host, the subject may not be able to cooperate with the clinical trial plan or be unsuitable to join for any other reason
Exclusion conditions for diagnostic imaging scans:
27. The subject has extensive early infarction in any affected part of MRI or CT, that is, the core of the infarct occupies> 1/3 of the MCA area or> 1/2 of the ACA or PCA area
28. Subjects with angiographic evidence of ICH or SAH (regardless of the age at which bleeding occurred); arteriovenous malformations; cerebral aneurysms; or brain tumors (incidental meningioma and microleakage are not excluded. Small size (< 5) (Mm) Occasional intracranial aneurysm, no thrombosis, and bleeding is not visible to the naked eye, it is not an exclusionary condition)
29. The subject has confirmed parenchymal hyperintensity on FLAIR, T2* or EPI-T2 angiography, or the obvious low density on CT indicates subacute cerebral infarction, or the intensity of the pattern characteristics indicates that the lesion has more than 9 hours
30. The subject has an internal carotid artery occlusion on the side of the stroke lesion
31. The subject has contraindications to contrast technology (ie, strong magnetic objects of MRI, contraindications to contrast agents, etc.. Please refer to the contraindications of contrast technology in the contrast manual)
32. The subject has any intracranial lesions that will interfere with the evaluation of the imaging technique used to perform the scan.
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
320 participants
