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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT03997292
Eligibility Criteria:
Inclusion Criteria:
* 1\) age\> 18 years old;
* 2\) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;
* 3\) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);
* 4\) within 3 hours of onset;
* 5\) Have measurable neurological deficits;
* 6\) Patients or legal guardians can understand and sign informed consent.
Exclusion Criteria:
* Absolute exclusion criteria:
* 1\) history of head trauma or stroke within the last 3 months;
* 2\) suspected subarachnoid hemorrhage;
* 3\) history of previous intracranial hemorrhage;
* 4\) intracranial tumor, arteriovenous malformation or aneurysm ;
* 5\) recent intracranial or intraspinal surgery;
* 6\) arterial puncture at an incurable site within the last 7 days;
* 7\) elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
* 8\) Internal bleeding;
* 9\) acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;
* 10\) heparin treatment within 48 h (APTT is outside the upper limit of normal range);
* 11\) oral anticoagulant, INR\> 1.7 Or PT\> 15S;
* 12\) are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;
* 13\) Blood glucose \<50 mg / dl (2.7 mmol / L);
* 14\) CT suggestive of multiple cerebral infarction (low density range\> 1/3 of the cerebral hemispheres) ;
* 15\) Other conditions considered unsuitable for inclusion in this clinical study;
* 16\) 3 months or are participating in other clinical trials;
* 17\) combined with severe systemic disease is expected to survive less than three months.
* Relative exclusion criteria:
* 1\) severe stroke (NIHSS\> 25 points);
* 2\) pregnancy;
* 3\) neurological deficits after epileptic seizures;
* 4\) major surgery or severe trauma within the last 14 days;
* 5\) Urethral hemorrhage;
* 6\) Myocardial infarction within the last 3 months;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03997292
Study Brief:
Protocol Section:
NCT03997292