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

Phase 4

Recruiting

• Conditions: Nervous System Diseases

• Registration Number: PACTR201905578860441
• Lead Sponsor: Faculty of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

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

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 < 10000/mm3, heparin received prior 48 hours with elevated PTT, or current use of anticoagulant (Coumadin /warfarin) with elevated INR.
9.Intra-cranial or spinal surgery, or head trauma within prior 3 months.
10. Arterial puncture at non compressible site within last 7 days.
11. Woman of child bearing age who has a positive pregnancy test.
12. NIH stroke scale>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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale MRS with MRS 0 to 1 as favorable outcome and MRS more than 2 as non favorable outcome.