Outcome in Patients Treated With Intraarterial Thrombectomy - optiMAL Blood Pressure Control (OPTIMAL-BP)

Ischemic Stroke Clinical Trial

Official title:

Outcome in Patients Treated With Intraarterial Thrombectomy - optiMAL Blood Pressure Control (OPTIMAL-BP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04205305
• Other study ID #: 4-2019-1208
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 18, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. The study is a multicenter, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study.

2. After successful revascularization, the active blood pressure control group and the standard blood pressure control group will be randomized by 1: 1.

3. Patients who is admitted to the Department of Neurology at the participating hospital with acute cerebral infarction will will be included for 5 years from December 2019 to December 2023 (based on the date of stroke). Patients who have undergone intraarterial thrombectomy and have successfully reopened arteries should be enrolled.

4. Collect medical history, laboratory findings and blood pressure parameters (systolic blood pressure, diastolic blood pressure, blood pressure variability, etc.), neurological scores, functional recovery, and quality of life indicators.

5. Neurological scores, functional recovery scores, and quality of life indicators are performed by independent researchers in the blind state.

6. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication.

7. Central adjudication will review the image study.

8. One intermediate analysis will be conducted at the end of first period or when a half of study patients were enrolled.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 306
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age =20 years

2. Acute ischemic stroke patients who underwent intraarterial treatment for large vessel occlusion. (ICA, MCA M1 or M2, ACA A1, PCA P1)

3. Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3) 4. Patients with elevated BP (systolic BP =140 mmHg) on at least two measurements with a two-minute interval within 2 hours of successful recanalization.

Exclusion Criteria:

1. Age <20

2. Patients with contraindication for use antihypertensive medication after intraarterial thrombectomy.

3. Patients with blood pressure <140 mmHg after successful recanalization.

4. Patients with symptomatic intracranial hemorrhage after successful recanalization

5. Patients with pre-morbid neurological dysfunction (modified Rankin Scale, mRS >2)

6. Patients with severe medical and surgical diseases.

7. Patients who are considered having a difficulty to enrollment.

8. No informed consents from patients.

9. Patients who participated in a study that did not allow duplicate participation

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• conventional blood pressure control (labetalol, nicardipine)
After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.
• intensive blood pressure control (labetalol, nicardipine)
After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure <140 mmHg.

Locations

Country	Name	City	State
Korea, Republic of	Department of Neurology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin scale scores(mRS)	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.	90 days
Primary	symptomatic intracerebral hemorrhage: Number of participants with symptomatic intracerebral hemorrhage	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.	36 hours
Primary	Death related to the index stroke within 90 days		90 days
Secondary	BP parameters - systolic blood pressure	change in systolic blood pressure	24 hour
Secondary	BP parameters - diastolic blood pressure	change in diastolic blood pressure	24 hour
Secondary	BP parameters - blood pressure variability	change in blood pressure variability	24 hour
Secondary	Functional independence	modified Rankin score 0 to 2	1 month
Secondary	Distribution of the modified Rankin scores (shift analysis)	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.	90 days
Secondary	National Institutes of Health Stroke Scale(NIHSS) score	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.	24 hour
Secondary	Excellent recovery	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.	24 hour
Secondary	Recanalization status on CT Angiography(CTA) or MR Angiography(MRA)	occurence of TICI 2b or 3 recanalization on CTA or MRA; - The thrombolysis in cerebral infarction(TICI) scale is a tool for determining the response of thrombolytic therapy for ischemic stroke. The original description 1 was based on the angiographic appearances of the treated occluded vessel and the distal branches(Grade 0: no perfusion, Grade 1: penetration with minimal perfusion, Grade 2: partial perfusion, Grade 2A: only partial filling(less than two-thirds) of the entire vascular territory is visualized, Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal, Grade 3: complete perfusion)	24±12 hour
Secondary	Quality of life measured by Euro-QoL	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.	90 days
Secondary	Number of participants with malignant brain edema	1) acute, complete MCA(middle cerebral artery) infarction with early parenchymal hypodensity of at least 50% of the MCA territory and signs of local brain swelling such as sulcal effacement and compression of the lateral ventricle; 2) midline shift of >5 mm at the septum pellucidum or pineal gland with obliteration of the basal cisterns; and 3) neurological deterioration consisting of a NIHSS increase by >2 points and decrease in the level of consciousness to a score of = 1 on item 1A of the NIHSS.	24 hour
Secondary	Number of participants with treatment failure	failure to achieve goal blood pressure(BP) for 2 consecutive BP measurements during the first 24 hours following EVT(endovascular thrombectomy)	24 hour
Secondary	CT or MRI ASPECTS(Alberta Stroke Program Early CT Score)	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.	36 hour