Intensive versus conventional blood pressure control after thrombectomy for anterior circulation stroke
Intensive Blood Pressure Control After Endovascular Thrombectomy for Acute Embolic Stroke (INTENSE): a Multicentre, Open-label, Blinded-endpoint, Randomised Controlled Trial
This trial will try whether keeping systolic blood pressure under 120 mmHg after successful thrombectomy leads to better 3-month outcomes than standard targets of 140–180 mmHg in adults with anterior circulation ischemic stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 910 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT07350564 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial assigns adults who have had successful anterior circulation thrombectomy and early elevated systolic blood pressure to either intensive BP lowering (target <120 mmHg) or conventional management (target 140–180 mmHg). Treatment targets are applied soon after reperfusion and patients are followed for three months to compare functional outcomes and safety events such as symptomatic intracranial hemorrhage and recurrent ischemia. Key inclusion criteria include mTICI ≥2b recanalization, ASPECTS ≥6, NIHSS ≤30, treatment within 24 hours of onset, and sustained SBP ≥140 mmHg within 3 hours of reperfusion. Outcomes are based on standardized clinical scales at 90 days with protocolized BP monitoring and antihypertensive therapy.
Who should consider this trial
Good fit: Adults (≥18) with acute anterior circulation ischemic stroke who achieve successful recanalization (mTICI ≥2b) after thrombectomy within 24 hours, have ASPECTS ≥6 and sustained systolic BP ≥140 mmHg early after reperfusion are ideal candidates.
Not a fit: Patients with significant pre-existing disability, failed or incomplete recanalization, posterior circulation strokes, or those with low baseline blood pressure are unlikely to benefit from intensive BP lowering in this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce secondary brain injury and improve functional recovery at three months after thrombectomy.
How similar studies have performed: Prior trials and observational studies of post-thrombectomy blood pressure targets have been limited and results mixed, making the intensive <120 mmHg strategy relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * To receive endovascular thrombectomy \<24 hours after the onset of symptoms * Diagnosed with acute anterior circulation ischemic stroke * National Institutes of Health Stroke Scale (NIHSS) score ≤ 30; * Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 * Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), or Digital Subtraction Angiography (DSA) confirming occlusion of the intracranial internal carotid artery or M1/M2 segment of the middle cerebral artery * Successful recanalization of the occluded vessel without in-situ or proximal stenosis (modified Treatment in Cerebral Infarction, mTICI ≥ 2b) * Sustained elevated systolic blood pressure (≥140 mmHg for at least two consecutive measurements, separated by \>10 minutes) within 3 hours of reperfusion * Written informed consent provided by the patient or their legal representative Exclusion Criteria: * Pre-existing stroke disability defined by a modified Rankin score (mRS) \>2 * Unlikely to benefit from or tolerate endovascular thrombectomy, such as severe allergic reaction to contrast agents * Failure to achieve mTICI ≥ 2b with endovascular intervention, or presence of in situ or proximal vascular stenosis * Patients with contraindications for the use of antihypertensive medications, such as allergy to components * Intracranial space-occupying lesions, including brain tumors and vascular malformations * Patients with severe liver or renal dysfunction, or those receiving dialysis (severe liver dysfunction is defined as alanine aminotransferase \[ALT\] \> 3 times the upper limit of normal or aspartate aminotransferase \[AST\] \> 3 times the upper limit of normal; severe renal dysfunction is defined as serum creatinine \> 3.0 mg/dL \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \< 30 mL/min/1.73 m²) * Serious illness with life expectancy of \<6 months * Lactating women * Participation in other interventional clinical trials within the past 3 months; * Any other conditions that render patients unsuitable for participation in this study or unable to complete the study process, such as psychiatric disorders, cognitive or emotional impairments, or physical conditions that hinder compliance with study procedures and follow-up
Where this trial is running
Suzhou, Jiangsu
- The Fourth Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
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.