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Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)

N

Nanjing Medical University

Status

Terminated

Conditions

Acute Ischemic Stroke

Treatments

Other: Intensive BP lowering

Study type

Interventional

Funder types

Other

Identifiers

NCT04775147
CRISIS I

Details and patient eligibility

About

CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.

Full description

CRISIS I aims to determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to standard BP management target (<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).

Enrollment

205 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years
  • Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging
  • To receive MT <24 hours after AIS onset according to local guidelines
  • Successful recanalization (TICI score ≥2b) after MT
  • Sustained systolic BP ≥140 mmHg (defined as 2 successive readings <10 mins) within 60 minutes after recanalization
  • Provide written informed consent (or approved surrogate)
  • Perform CTA or MRI before endovascular therapy
  • Signed an approved informed consents

Exclusion criteria

  • Significant pre-stroke disability (mRS scores 2-5)
  • Definite indication/contraindication to different intensities of BP lowering treatment
  • Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients)
  • Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician
  • Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating
  • Other conditions inappropriate for inclusion judged by investigators

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

205 participants in 2 patient groups

Intervention group
Experimental group
Description:
Achieving SBP level of \<120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.
Treatment:
Other: Intensive BP lowering
Control group
No Intervention group
Description:
Maintaining SBP level of \<140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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