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The primary objective of the study is to assess the safety of N-Acetylcysteine as a thrombolytic agent in acute ischemic stroke, especially regarding the risk of hemorrhagic transformation.
Preclinical studies demonstrated that N-Acetylcysteine (NAC) is able to break von Willebrand Factor (VWF) multimers by bisulfide bond reduction. Since thrombi in stroke patients are rich in VWF, NAC could be used as a thrombolytic agent during the acute phase. This study aims at assessing the safety of NAC in combination with alteplase (rt-PA) at the acute phase of ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine 150 mg/kg | Experimental | Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetyl cysteine | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhagic transformation | Rate of symptomatic hemorrhagic transformation according to the SITS-MOST criteria: a local or remote parenchymal hemorrhage on imaging 22 to 36 hours after treatment or earlier if the imaging scan was performed due to clinical deterioration combined with a neurological deterioration of >4 NIHSS points from baseline or from the lowest NIHSS score between baseline and 24 hours or leading to death within 24 hours. | 22 to 36 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Extracranial hemorrhagic events | Rate of extracranial hemorrhagic events | Up to 3 months after treatment |
| Treatment related side effects | Rate of any drug related side effects according to the Common Terminology Criteria of Adverse Event 5.0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Caen | Normandy | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28487393 | Background | Martinez de Lizarrondo S, Gakuba C, Herbig BA, Repesse Y, Ali C, Denis CV, Lenting PJ, Touze E, Diamond SL, Vivien D, Gauberti M. Potent Thrombolytic Effect of N-Acetylcysteine on Arterial Thrombi. Circulation. 2017 Aug 15;136(7):646-660. doi: 10.1161/CIRCULATIONAHA.117.027290. Epub 2017 May 9. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Up to 3 months after treatment |
| Mortality and functional independence | Rate of mortality and functional independence at 3 months according to the modified Rankin scale (mRs) | 3 months after treatment |
| Early neurological improvement | Rate of early neurological improvement defined as an improvement of >4 NIHSS points 24 hours after treatment. | 24 hours after treatment |
| Plasma VWF multimers | Mean size of VWF multimers before and after treatment | Before, at 3 hours and at 24 hours after treatment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |