Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02180204
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 80 years
2. Acute neurologic deficit with an NIHSS ≥ 4
3. Non-enhanced computed tomography (NECT) of the head showing no hemorrhage
4. Acute ischemic stroke symptoms with onset, or time last known well, clearly defined between 3 and 4.5 hours
5. Treatment can be initiated within 3 to 4.5 hours from symptom onset
Exclusion Criteria:
1. Evidence of intracranial hemorrhage on NECT
2. Clinical suspicion of subarachnoid hemorrhage even with normal NECT
3. NECT shows hypo-density greater than 1/3 cerebral hemisphere)
4. History of intracranial hemorrhage/stroke
5. Uncontrolled HTN: At time treatment begins SBP remains \>185 mmHg or DBP remains \>110 mmHg despite repeated measurements
6. Known arteriovenous malformation, neoplasm, or aneurysm
7. Witnessed seizure at stroke onset
8. Acute bleeding tendencies
9. Platelet count \<100,000/mm3
10. Heparin received in prior 48 hours with elevated aPTT
11. Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR
12. Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban)
13. Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke
14. Arterial puncture at non-compressible site within last 7 days
15. Woman of child bearing age who has a positive pregnancy test
16. NIH stroke scale \>25 (severe deficit) or \<4 and no dysphasia (mild deficit) or rapidly improving
17. Symptoms spontaneously clearing
18. 14 days post-operative or post major trauma
19. Recent gastrointestinal or urinary tract hemorrhage within the past 21 days
20. Recent acute MI within the past 3 months
21. Serum glucose \<50 mg/dl or \>400 mg/dL
22. Age \>80 or less than 18
23. History of ischemic stroke AND diabetes mellitus
24. Unable to obtain consent from patient or power of attorney
25. Baseline mRS \> 2
26. Consent not obtained by 20 minutes prior to closure of the therapeutic window.
27. The subject has been treated with a thrombolytic agent within the past 72 hours
28. The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy)
29. The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02180204
Study Brief:
Protocol Section:
NCT02180204