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Comparison of efficacy and safety of intravenous Alteplase (rt-PA) versus Aspirin therapy to improve outcome in patients with acute ischemic stroke

Comparison of efficacy and safety of intravenous Alteplase (rt-PA) versus Aspirin therapy to improve outcome in patients with acute ischemic stroke

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR201905578860441
Enrollment
80
Registered
2019-05-13
Start date
2018-01-28
Completion date
Unknown
Last updated
2026-09-14

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 group
Aspirin

Sponsors

Faculty of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1- Age 18 year or older 2- Clinical diagnosis of ischemic stroke with measurable neurological deficit.

Exclusion criteria

Exclusion criteria: 1. Evidence of intra-cranial hemorrhage on non-contrast CT (computerized tomography). 2. Clinical suspicion of sub-arachnoid hemorrhage even with normal CT. 3. CT shows multi-lobar infarction (hypo-density greater than 1/3 cerebral hemisphere). 4. History of intra-cranial hemorrhage. 5. Uncontrolled hypertension: at time treatment systolic blood pressure remains>185 mm hg or diastolic blood pressure remains>110 despite repeated measurements. 6. Known arteriovenous malformation, neoplasm, or aneurysm. 7. Witnessed seizure at stroke onset. 8. Acute bleeding tendencies as low platelet count 22 (sever deficit) or <4 and no dysphasia (mild deficit) or rapidly improving symptoms. 13. 14 days post-operative or post trauma. 14. Recent GI or urinary tract hemorrhage (prior 21 days). 15. Recent acute myocardial infarction (prior 3 months). 16. Post myocardial infarction pericarditis. 17. Glucose level < 50 which is resistant for correction by glucose infusion.

Design outcomes

Primary

MeasureTime frame
is assessed changes in neurological deficits 24 hours after the onset of stroke as a measure of the activity of t-PA by National Institution of Health Stroke Scale NIHSS interpretation. Early neurological improvement was defined as an NIHSS score of 0 or 1 at 24 h after treatment or a decrease of 4 points or more in NIHSS score at 24 h after treatment.

Secondary

MeasureTime frame
Modified Rankin Scale MRS with MRS 0 to 1 as favorable outcome and MRS more than 2 as non favorable outcome.

Countries

Egypt

Contacts

Public ContactNadia;Amr Mohee El Din Bahgat Abbas;El fatatrey

Lecturer of Anesthesiology and Intensive Care;Assistant Professor of Neuropsychiatry Faculty of Medicine Alexandria University

dr_nmbahgat@yahoo.com;amrelfatatry@gmail.com00201009558238;01223925467

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026