Optimizing Blood Pressure Control After Thrombectomy for Stroke
Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
This study tests whether managing blood pressure more tightly after a stroke treatment helps patients recover better and improves their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06677970 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different blood pressure management strategies in patients who have undergone endovascular thrombectomy for acute ischemic stroke. Participants will be randomly assigned to either an intensive blood pressure control group or a standard control group, with outcomes assessed by independent evaluators. The study aims to determine the optimal blood pressure target to improve functional recovery and quality of life after the procedure. Data will be collected on various health parameters, including neurological scores and blood pressure variability, over a multi-center study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who have undergone successful endovascular thrombectomy for acute ischemic stroke due to large vessel occlusion.
Not a fit: Patients who are younger than 20 or those who did not achieve successful recanalization after thrombectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for patients who have suffered an acute ischemic stroke.
How similar studies have performed: Previous studies have shown mixed results regarding blood pressure management post-thrombectomy, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
\<Inclusion Criteria\> 1. Age ≥20 years 2. Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion. (ICA, M1, M2, A1, P1, VA and BA) 3. Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3) 4. Patients with sustained systolic blood pressure (SBP) \<150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion. 5. Patients with mean SBP \<150 mmHg within 2 hours after successful recanalization (two measurements ≥2 minutes apart). \<Exclusion Criteria\> 1. Age \<20 2. Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a). 3. Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization. 4. Patients unable to receive antihypertensive medication post-thrombectomy or in whom the investigator believes aggressive blood pressure control could have adverse effects, such as increased risk of hemorrhage. 5. Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization. 6. Patients with contraindications to Phenylephrine. 7. Patients with contraindications to antihypertensive medications. 8. Patients with pre-stroke functional disability (modified Rankin Scale, mRS ≥3). 9. Patients with heart failure and reduced cardiac output, with an ejection fraction (EF) \<40%. 10. Patients with end-stage renal disease requiring renal replacement therapy, or chronic kidney disease stage 4 with an eGFR \<30 mL/min. 11. Patients currently taking monoamine oxidase (MAO) inhibitors. 12. Patients with persistent bradycardia with a heart rate \<45 bpm. 13. Pregnant patients. 14. Patients with severe medical or surgical comorbidities, including but not limited to: terminal cancer with life expectancy \<6 months, severe cardiac or aortic disease, severe hematologic disorders, advanced chronic heart failure, severe pneumonia, or sepsis. 15. Patients who do not consent to participate in the study. 16. Patients participating in another study that does not allow co-enrollment. 17. Patients whom the investigator deems unsuitable for study participation for any reason.
Where this trial is running
Seoul, Seoul
- Department of Neurology, Yonsei University College of Medicine — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hyo Suk Nam, MD,PhD
- Email: hsnam@yuhs.ac
- Phone: 82-2-2228-1617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.