Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02) "Revacept/CS/02"

Recruiting

Phase 2 Results N/A

Update History

3 Jul '17
The gender criteria for eligibility was updated to "All."
17 Sep '15
The Summary of Purpose was updated.
New
Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet monotherapy or monotherapy alone. Patients receive a single dose of trial medication by intravenous infusion for 20 minutes. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.
Old
Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke and presenting with microembolic signals (MES) receive either Revacept (single dose) plus antiplatelet monotherapy (Aspirin or Clopidogrel) or monotherapy alone with the aim of reducing MES. Patients receive a single dose of trial medication by intravenous infusion for 20 minutes. The primary endpoint (MES 24 hours after treatment) is assessed. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria - TIA, amaurosis fugax or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis - Oral anticoagulation or dual anti-platelet therapy with aspirin or clopidogrel and other P2Y inhibitors at screening (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg) - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present)
Old
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA, amaurosis fugax or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis - Oral anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) at screening; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours - Indication for oral anticoagulation
2 Oct '14
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA, amaurosis fugax or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis - Oral anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) at screening; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours - Indication for oral anticoagulation
Old
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA, amaurosis fugax or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - Ipsilateral siphon or middle cerebral artery stenosis (tandem stenosis) - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis - Oral anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) within the last 3 weeks; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours - Indication for oral anticoagulation
2 Aug '14
A location was updated in London.
New
The overall status was updated to "Recruiting" at 26 - University College London Hospital.
5 Apr '14
A location was updated in Manchester.
New
The overall status was updated to "Recruiting" at 24 - University of Manchester.
20 Feb '14
A location was updated in Coventry.
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The overall status was updated to "Recruiting" at 23 - University Hospital Coventry NHS Trust.
7 Feb '14
A location was updated in Bochum.
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The overall status was updated to "Recruiting" at Site 10: Universitätsklinikum der Ruhr-Universität Bochum.
A location was updated in Cambridge.
New
The overall status was updated to "Recruiting" at 25 - Addenbrookes Hospital.
A location was updated in London.
New
The overall status was updated to "Recruiting" at Site 20: St George's NHS Trust.
7 Sep '13
A location was updated in Mainz.
New
The overall status was updated to "Recruiting" at Site 09: Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie.
11 Jul '13
A location was updated in Essen.
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The overall status was updated to "Recruiting" at Site 08: Universitätsklinikum Essen, Klinik für Neurologie.
A location was updated in Ulm.
New
The overall status was updated to "Recruiting" at Site 06: Universitätsklinikum Ulm, Abteilung für Neurologie.
21 Jun '13
A location was updated in Hannover.
New
The overall status was updated to "Recruiting" at Site 07: Medizinische Hochschule Hannover, Klinik für Neurologie.
A location was updated in Regensburg.
New
The overall status was updated to "Recruiting" at Site 05: Klinik und Poliklinik für Neurologie der Universität Regensburg.
11 May '13
The Summary of Purpose was updated.
New
Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke and presenting with microembolic signals (MES) receive either Revacept (single dose) plus antiplatelet monotherapy (Aspirin or Clopidogrel) or monotherapy alone with the aim of reducing MES. Patients receive a single dose of trial medication by intravenous infusion for 20 minutes. The primary endpoint (MES 24 hours after treatment) is assessed. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.
Old
Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs) or stroke, who are scheduled for carotid endarterectomy (CEA) and presenting with microembolic signals (MES) receive either Revacept (single dose) plus antiplatelet monotherapy (Aspirin or Clopidogrel) or monotherapy alone with the aim of reducing MES. Patients receive a single dose of trial medication by intravenous infusion for 20 minutes before CEA. The primary endpoint (MES 24 hours after treatment) is assessed before CEA intervention. Patients are followed up on the day of CEA intervention; one day after CEA, at 3 months and by a telephone interview at 12 months.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA, amaurosis fugax or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - Ipsilateral siphon or middle cerebral artery stenosis (tandem stenosis) - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis - Oral anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) within the last 3 weeks; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours - Indication for oral anticoagulation
Old
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with greater than or equal to 50 % stenosis according to the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria - Flow velocity greater than or equal to 200 cm/sec - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - Ipsilateral siphon or middle cerebral artery stenosis (tandem stenosis) - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Haemorrhagic transformation or recent strokes with focal hypodensity corresponding to middle cerebral artery territory as determined by CT or anamnesis - Oral anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) within the last 3 weeks; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours - Indication for oral anticoagulation
1 May '13
A location was updated in Tübingen.
New
The overall status was updated to "Recruiting" at Universitätsklinikum Tübingen, Klinik für Allgemeine Neurologie.
15 Mar '13
A location was updated in Tutzing.
New
The overall status was updated to "Recruiting" at Benedictus Krankenhaus Tutzing GmbH u. Co. KG.
24 Nov '12
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with greater than or equal to 50 % stenosis according to the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria - Flow velocity greater than or equal to 200 cm/sec - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - Ipsilateral siphon or middle cerebral artery stenosis (tandem stenosis) - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Haemorrhagic transformation or recent strokes with focal hypodensity corresponding to middle cerebral artery territory as determined by CT or anamnesis - Oral anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) within the last 3 weeks; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours - Indication for oral anticoagulation
Old
Inclusion Criteria: 1. Signed written informed consent 2. Target population - Diagnosis: - Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography) - Lesions with greater than or equal to 50 % stenosis according to the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria - Flow velocity greater than or equal to 200 cm/sec - MES detected by TCD (greater than or equal to 1 MES per hour) - Ipsilateral TIA or stroke within the last 30 days - Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised. Exclusion Criteria: 1. Sex and reproductive Status: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2. Target disease exceptions - Ipsilateral siphon or middle cerebral artery stenosis (tandem stenosis) - NIHSS score > 18 - Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR) - Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves) 3. Medical history and concurrent disease - History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug - History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT)) - Thrombolysis within the last 48 hours - Haemorrhagic transformation or recent strokes with focal hypodensity corresponding to middle cerebral artery territory as determined by CT or anamnesis - Anticoagulation or other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release) - Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension - History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis - Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit) - Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis - Known atrial fibrillation or other clinically significant ECG abnormalities (at present) 4. Prohibited Treatments and/or therapies - Anticoagulation or dual antiplatelet therapy within the last 3 weeks - Indication for anticoagulation
4 Oct '12
A location was updated in Munich.
New
The overall status was updated to "Recruiting" at Department of Neurology, TU Munich.