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

NCT04775147 | Terminated DMC

• 1 other identifier: CRISIS I
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Mechanical thrombectomy; Blood pressure management

Outcome Measures

Primary Outcomes (1)

• Level of disability

  a shift (improvement) in scores (0-6) on the modified Rankin scale

  90 days (3months)

Secondary Outcomes (3)

• Intracerebral hemorrhage

  90 day

• Death or neurological severity

  7 days

• BP lowering target (<120 mmHg)

  3 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Achieving SBP level of \<120mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.

Other: Intensive BP lowering

Control group

NO INTERVENTION

Maintaining SBP level of \<140mmHg within 1 hour after successful recanalization, and maintaining this level at least 72 hours.

Interventions

Intensive BP lowering OTHER

The aim is to achieve a systolic BP level of \<120mmHg within 1hour after successful recanalization and to maintain this BP level for the next 72 hours (or until hospital discharge or death of this should occur earlier)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open intervention; outcome assessments undertaken by trained research staff who are kept blind to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: July 3, 2020
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: July 24, 2023

Record last verified: 2022-04

Locations

CN (1)