---
title: Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
nct_id: NCT05175547
overall_status: COMPLETED
phase: PHASE3
sponsor: ProMedica Health System
study_type: INTERVENTIONAL
primary_condition: Stroke, Acute
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05175547.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05175547"
ct_last_update_post_date: 2025-01-07
last_seen_at: "2026-05-12T06:43:08.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke

**Official Title:** Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)

**NCT ID:** [NCT05175547](https://clinicaltrials.gov/study/NCT05175547)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** ProMedica Health System
- **Conditions:** Stroke, Acute, Blood Pressure, Mechanical Thrombectomy
- **Start Date:** 2021-10-30
- **Completion Date:** 2024-02-28
- **CT.gov Last Update:** 2025-01-07

## Brief Summary

The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset.

## Detailed Description

The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120mmHg (Intensive BP management group) or 90-160mmHg (Standard BP management group). Patients enrolled into the study will be followed and assessed for up to 3 months.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 1\. Age 18 or older
* 2\. Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
* 3\. Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1, or M2) on angiogram with mechanical thrombectomy initiated within 24 hours since last known well
* 4\. Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
* 5\. ASPECTS score of greater than 6
* 6\. Premorbid mRS 0-4
* 7\. Signed informed consent within 30 minutes from end of MT procedure.

Exclusion Criteria:

* 1\. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
* 2\. Pregnant or lactating
* 3\. Acute traumatic brain injury
* 4\. Patient on active dialysis
* 5\. Intracranial neoplasm
* 6\. Acute or recent STEMI in the last 30 days
* 7\. Severe arrhythmias, unstable cardiac function
* 8\. Any terminal medical condition with life expectancy less than 6 months
* 9\. Concurrent enrollment in another trial that could confound the results of this study
```

## Arms

- **Intensive blood pressure management group** (ACTIVE_COMPARATOR) — Target blood pressure of 90-120mmHg (Intensive BP management group)
- **Standard blood pressure management group** (ACTIVE_COMPARATOR) — Target blood pressure of 90-160mmHg (Standard BP management group)

## Interventions

- **Clevidipine** (DRUG) — Blood pressure management with Clevidipine

## Primary Outcomes

- **Primary Efficacy Endpoint (Drug-related)** _(time frame: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration)_ — Time to target blood pressure
- **Primary Safety Endpoint (Disease-related)** _(time frame: 24 hours from the time of treatment with Clevidipine)_ — Incidence of any hemorrhagic conversion at 24 hours

## Secondary Outcomes

- **Drug-related** _(time frame: Up to 24 hours after study drug adminstration)_
- **Drug-related, Rate of hypotension requiring intervention** _(time frame: Up to 24 hours after study drug adminstration)_
- **Drug-related, Rate of hypotension and severe hypertension** _(time frame: Up to 24 hours after study drug adminstration)_
- **Disease-related, Incidence of symptomatic intracerebral hemorrhage** _(time frame: Within 24 hours of randomization)_
- **Disease-related, Delayed ICH after 24 hours** _(time frame: Within 24 hours of randomization)_
- **Disease-related, Incidence of acute kidney injury** _(time frame: From drug adminstration to 90 days post-randomization)_
- **Disease-related,** _(time frame: 90 days after randomization)_
- **Disease-related, Length of hospital stay** _(time frame: Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner))_
- **Disease-related, Use of additional hypertensive agents** _(time frame: Up to 24 hours after study drug adminstration)_
- **Disease-related, Onset of atrial fibrillation or cardiovascular events** _(time frame: Up to 24 hours after study drug adminstration)_
- **Disease-related, mRS 0-2 or return to baseline at 90 days** _(time frame: 90 days post-randomization)_

## Locations (1)

- ProMedica Toledo Hospital, Toledo, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.promedica toledo hospital|toledo|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05175547.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05175547*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*