NCT06677970 Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
| NCT ID | NCT06677970 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yonsei University |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2029-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 176 participants in total. It began in 2024-10-01 with a primary completion date of 2029-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion. Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in patients with sustained systolic blood pressure (SBP) \<150 mmHg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion. This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at less than 160 mmHg) or a standard BP control group (systolic BP at or below 180 mmHg).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06677970 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06677970 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 176 participants.
Is NCT06677970 currently recruiting?
Yes, NCT06677970 is actively recruiting participants. Contact the research team at hsnam@yuhs.ac for enrollment information.
Where is the NCT06677970 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06677970 clinical trial?
NCT06677970 is sponsored by Yonsei University. The trial plans to enroll 176 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.