Recruiting PHASE3 Acute Ischemic Stroke

New treatment option for Acute Ischemic Stroke

Official title Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)

ClinicalTrials.gov ID: NCT06677970

What this study is testing

What is BP lowering drugs (nicardipine, labetalol, urapidil)?

BP lowering drugs (nicardipine, labetalol, urapidil) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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%.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 20 and older

You may be able to join if

  • Age ≥20 years
  • Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion. (ICA, M1, M2, A1, P1, VA and BA)
  • Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3)
  • Patients with sustained systolic blood pressure (SBP) \<150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after...
  • Patients with mean SBP \<150 mmHg within 2 hours after successful recanalization (two measurements ≥2 minutes apart). \<

You likely can't join if

  • Age \<20
  • Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a).
  • Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization.
  • Patients unable to receive antihypertensive medication post-thrombectomy or in whom the investigator believes aggressive blood pressure control could...
  • Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization.
  • Patients with contraindications to Phenylephrine.
See the full eligibility criteria
Who can join
  • Age ≥20 years
  • Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion. (ICA, M1, M2, A1, P1, VA and BA)
  • Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3)
  • Patients with sustained systolic blood pressure (SBP) \<150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
  • Patients with mean SBP \<150 mmHg within 2 hours after successful recanalization (two measurements ≥2 minutes apart). \<
What rules you out
  • Age \<20
  • Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a).
  • Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization.
  • 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.
  • Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization.
  • Patients with contraindications to Phenylephrine.
  • Patients with contraindications to antihypertensive medications.
  • Patients with pre-stroke functional disability (modified Rankin Scale, mRS ≥3).
  • Patients with heart failure and reduced cardiac output, with an ejection fraction (EF) \<40%.
  • Patients with end-stage renal disease requiring renal replacement therapy, or chronic kidney disease stage 4 with an eGFR \<30 mL/min.
  • Patients currently taking monoamine oxidase (MAO) inhibitors.
  • Patients with persistent bradycardia with a heart rate \<45 bpm.
  • Pregnant patients.
  • 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...
  • Patients who do not consent to participate in the study.
  • Patients participating in another study that does not allow co-enrollment.
  • Patients whom the investigator deems unsuitable for study participation for any reason.

The study team makes the final eligibility decision.

Where it's taking place

  • Seoul, Seoul, South Korea

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.