Efficacy and Safety of Tenecteplase versus Alteplase in Thrombolysis of Ischemic Stroke in developping country. (ESTATIS)

Phase 4

Recruiting

• Conditions: Nervous System Diseases

• Registration Number: PACTR202202707050206
• Lead Sponsor: Hassan II unversity hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Man or woman not pregnant = 18 years old.
- Clinical picture suggestive of a stroke
- <4.5h after the onset of symptoms.
- cerebral CT or cerebral MRI showing no hemorrhage
- Informed consent of the patient or his legal representative.
- Independent before stroke (Modified Rankin scale estimated 0-1).

Exclusion Criteria

- Evidence of intracranial hemorrhage
- Other significant intracranial pathology without cerebrovascular accident likely to account for clinical presentation or risk of intracerebral hemorrhage (eg central nervous system neoplasm) in computed tomography (CT) pretreatment
- stroke within the previous 14 days, thrombolytic therapy within the last 14 days, or CT scan hypodensity pretreatment consistent with recent cerebral ischemia other than the presentation event
- systolic blood pressure greater than 185 or diastolic blood pressure greater than 110 mmHg, or which remains greater than 185 or diastolic blood pressure greater than 110 mmHg despite adequate intravenous drug management) necessary to lower the blood pressure to these limits
- Clinical history suggestive of subarachnoid hemorrhage, even if no blood is visible during a computed tomography (CT) scan
- High risk of bleeding, including major surgery, trauma or gastrointestinal or urinary hemorrhage during the previous 21 days; Arterial puncture at a non-compressible site within the previous 7 days; Extended cardiopulmonary resuscitation (> 2 minutes) in the previous 14 days; Acute pericarditis and / or subacute bacterial endocarditis; acute pancreatitis; Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis; Active peptic ulceration; History of Hemorrhagic Stroke Known Fate of Coagulation or Platelet Function (Other than Antiplatelet Therapy)
- Hypo- or hyperglycemia (blood glucose <2 mmol / l or> 18 mmol / l) sufficient to explain neurological symptoms; Seizure at onset of symptoms unless brain imaging identifies positive signs of significant cerebral ischemia (eg, early ischemic change with ASPECTS score <7/10)
- Pregnancy (for women of childbearing age, a negative pregnancy test will be required before randomization);
- Insufficient haemostasis:
o Patient on anti-vitamin K therapy and International Standard Report (INR)> 1.3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale [Timeline: Day 90 (+/- 7)] See Annex 1<br>Modified Rankin Scale (mRS) at day 90, during the 90-day consultation or determined by Telephone.

Secondary Outcome Measures

Name	Time	Method
- Complete neurological recovery (modified Rankin scale 0-1 vs. 2-6). <br>;Independent recovery (Modified Rankin Score changed 0-2 vs. 3-6). ;Early major neurological improvement of 8 points or more, or return to the National Institutes of Health Stroke Scale (NIHSS) score of 0 or 1 to 24 hour (s).;Score of Barthel's index ;Mortality ;Neurological deterioration NIHSS score increase = 4 points from baseline ;Intracerebral symptomatic haemorrhage (SICH) Parenchymatous hematoma type 2 (PH2) haemorrhage on cerebral CT until 36 hours after treatment. ;Any intracranial hemorrhage on a CT scan ;Significant extracranial haemorrhage (need for blood transfusion or hemoglobin drop =20 mg / l within 36 hours after treatment).