Department of Neurology, Yonsei University College of Medicine
Seoul, 120-752, South Korea
NCT Number: NCT04205305
Recent endovascular thrombectomy (EVT) trial have proven the effectiveness of intraarterial revascularization in patients with larger cerebral artery occlusion. The success rate of EVT is close to 80%, but only 50% of patients improve to independent functional outcome. Therefore, new treatment strategies are needed to reduce the futile revascularization. However, updated guidelines recommend the indications for EVT based on the results of randomized clinical trials (RCT), management of post-revascularization is largely unknown.
Current guidelines suggest that systolic blood pressure should be adjusted below 180 mmHg and diastolic blood pressure below 105 mmHg in patients undergoing intraarterial reopening. However, in the case of successful recanalization by EVT, same guideline is adopted even though the possibility of intracerebral hemorrhage or reperfusion injury by high blood pressure. On the other hand, too low blood pressure can worsen cerebral ischemia.
Therefore, this study will compare the effectiveness of active blood pressure control group (with less than 140 mmHg systolic blood pressure) versus standard blood pressure control group (with less than 180 mmHg systolic blood pressure) during the first 24 hours in patients who underwent EVT and achieved successful recanalization (TICI 2b-3). The goal is to reach the target blood pressure within 60 minutes of randomization.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Phase 4
Seoul, 120-752, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.
After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure <140 mmHg.
Time frame: 90 days
Effectiveness outcome: Functional independence (modified Rankin score 0 to 2)
-The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Time frame: 36 hours
Safety outcome: The definition in the European Cooperative Acute Stroke Study III (ECASS 3) will be adopted : a large local or remote parenchymal pattern (>30% of the infarcted area affected by hemorrhage, with mass effect or extension outside the infarct), intraventricular hemorrhage, or subarachnoid hemorrhage which is identified as the predominant cause of the neurologic deterioration from baseline (increase of ≥4 points in the NIHSS score) or death within 36 hours.
Time frame: 90 days
Time frame: 24 hour
change in systolic blood pressure
Time frame: 24 hour
change in diastolic blood pressure
Time frame: 24 hour
change in blood pressure variability
Time frame: 1 month
modified Rankin score 0 to 2
Time frame: 90 days
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Time frame: 24 hour
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Time frame: 24 hour
NIHSS 0 -1 or improvement more than 8. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Time frame: 24±12 hour
occurence of TICI 2b or 3 recanalization on CTA or MRA
Time frame: 90 days
EuroQol-5D (EQ-5D) is an instrument for measuring quality of life. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.
Time frame: 24 hour
Time frame: 24 hour
failure to achieve goal blood pressure(BP) for 2 consecutive BP measurements during the first 24 hours following EVT(endovascular thrombectomy)
Time frame: 36 hour
Alberta Stroke Program Early CT Score(ASPECTS) is a 10-point quantitative score used to assess early ischemic changes on non-contrast CT head.
To compute the ASPECTS, 1 point is subtracted from 10 for any evidence of early ischemic change for each of the defined regions. Identifying patients with a greater likelihood of poor functional outcome (scores <8) may be helpful in the early stages of care for supporting transfer or therapy decisions.
Yonsei University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01840072
Brain Diseases, Cardiovascular Diseases
Suzhou, Jiangsu, China
View Trial DetailsNCT01422616
Brain Diseases, Cardiovascular Diseases
Sydney, New South Wales, Australia
View Trial DetailsNCT03231293
Brain Diseases, Brain Ischemia
Ansan, South Korea
View Trial DetailsNCT03024476
Brain Diseases, Cardiovascular Diseases
Seongnam-si, Gyeonggi-do, South Korea
View Trial Details