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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202202707050206
Enrollment
80
Registered
2022-02-10
Start date
2019-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases

Interventions

Alteplase stroke thrombolysis with standard care
Tenecteplase stroke thrombolysis

Sponsors

Hassan II unversity hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 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 1.3

Design outcomes

Primary

MeasureTime frame
Modified Rankin scale [Timeline: Day 90 (+/- 7)] See Annex 1 Modified Rankin Scale (mRS) at day 90, during the 90-day consultation or determined by Telephone.

Secondary

MeasureTime frame
- Complete neurological recovery (modified Rankin scale 0-1 vs. 2-6). ;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).

Countries

Morocco

Contacts

Public ContactNaima CHTAOU

Assistant professor

naimachtaou@gmail.com+212664838010

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026