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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT03585595
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged ≥40 years
* A history of symptomatic, MRI/CT-confirmed ischemic stroke (3-12 months since last acute onset)
* Systolic BP ≥140 mmHg on 0 medication; 135-180 mmHg on 1 medication; 135-170 mmHg on up to 2 medications; 135-160 mmHg on up to 3 medications; or 135-150 mmHg on up to 4 medications
Exclusion Criteria:
* Documented symptomatic intracranial and/or extracranial stenosis (≥50%), or asymptomatic intracranial and/or extracranial stenosis (≥70%)
* Disabling stroke (modified Rankin score of ≥4)
* Previous intracranial hemorrhage from a non-traumatic cause
* Any symptoms of orthostatic hypotension during the standing BP measurement, or standing systolic BP \<110 mmHg
* Severe heart failure (NY Heart Association class III and IV) within the past six months or left ventricular ejection fraction (by any method) \<35%
* Any history of atrial fibrillation, ventricular aneurysm, or suspicion of cardioembolic pathology for stroke
* Other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)
* Dialysis, eGFR \<20 ml/min/1.73 m2, urine protein-to-creatinine ratio ≥1 g/g, or albumin-to-creatinine ratio ≥ 600 mg/g
* Planned or probable revascularization (any angioplasty or vascular surgery) within three months after screening
* A medical condition likely to limit survival to less than three years
* A cancer diagnosed and treated within the past two years that, in the judgment of clinical study staff, would compromise a participant's ability to comply with the protocol and complete the trial (except non-melanoma skin cancer, early-stage prostate cancer, or localized breast cancer)
* Any factors judged by the clinic team to be likely to limit adherence to the intervention
* Failure to obtain informed consent from a participant
* Currently participating in another intervention study
* Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03585595
Study Brief:
Protocol Section:
NCT03585595