Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®)

NCT03300479 | Withdrawn Phase 4

• 1 other identifier: 2017-00379
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Intracerebral hemorrhage (ICH) is responsible for 10-15% of primary strokes. ICH is a dynamic process with three phases: initial hemorrhage, followed by hematoma expansion and perihematoma edema formation. Hematoma volume is correlated with disease progression and outcome. Contemporary evidence proposes that elevated blood pressure is associated with hematoma expansion while more than 90% of patients with ICH present with acute hypertension. Uncontrolled blood pressure is a leading cause of ICH and it seems also to be a factor of poorer outcomes. Therefore, rapid reduction and control of blood pressure might ease disease progression and improve the outcome. Clevidipine (Cleviprex®), an ultrashort-acting dihydropyridine calcium channel antagonist, with its rapid onset and short duration might be more effective than conventional antihypertensives to achieve rapid blood pressure control in patients with acute ICH.

Conditions

Nontraumatic Intracerebral Hemorrhage, Multiple Localized

Keywords

nontraumatic intracerebral hemorrhage; Cleviprex®; Ebrantil®; Systolic blood pressure

Outcome Measures

Primary Outcomes (1)

• Achieving the target systolic blood pressure

  Number of patients achieving the target systolic blood pressure (SBP) values (160 -120 mmHg) within 30 minutes after initiation of Clevidipine (Cleviprex®) or Urapidil (Ebrantil®)

  1/2 hours

Secondary Outcomes (7)

• Hypertensive burden - time

  24 hours

• Hypotensive burden - time

  24 hours

• Cumulative time out

  24 hours

• Blood pressure variability

  48 hours

• Hematoma growth

  6 hours

Other Outcomes (1)

• Costs

  24 hours

Study Arms (2)

Clevidipine

EXPERIMENTAL

The treatment starts at admission to the ICU for 24 hours with 2 mg to a maximum of 16 mg Clevidipine per hour infused intravenously and continuously to reach the systolic target pressure \< 160 mmHg (\>120 mmHg).

Drug: Clevidipine

Urapidil

ACTIVE COMPARATOR

The treatment starts at admission to the ICU for 24 hours with 5 mg to a maximum of 40 mg Urapidil per hour infused intravenously and continuously to reach the systolic target pressure \< 160 mmHg (\>120 mmHg).

Drug: Urapidil

Interventions

Clevidipine DRUG

Intravenous antihypertensive therapy with Clevidipine for the first 24 hours in patients with nontraumatic intracerebral hemorrhage (ICH).

Also known as: Cleviprex®

Clevidipine

Urapidil DRUG

We compare the therapy with Urapidil to Clevidipine for the acute phase (24 hours) in patients with ICH. We would like to show the efficacy and safety of Clevidipine in this special situation.

Also known as: Ebrantil®

Urapidil

Eligibility Criteria

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

You may qualify if:

• Primary intracerebral hemorrhage (ICH)
• Systolic blood pressure (SBP) \> 160 mmHg at screening
• Systolic blood pressure (SBP) \<160 mmHg under intravenous antihypertensive drug (e.g. Urapidil), started less than 3 h before randomization
• to unlimited years of age
• Signed informed consent obtained

You may not qualify if:

• Patients with secondary hemorrhage (bleeding source as aneurysm, arteriovenous malformation or traumatic)
• Patients with concomitant severe critical illness (e.g. sepsis, multi-organ failure)
• Positive pregnancy test for any female of childbearing potential or breast feeding female
• Known allergy to any component of Clevidipine (Cleviprex®), Urapidil Ebrantil®), soya bean oil or severe egg protein allergy
• Contraindications for Clevidipine (Cleviprex®): defect in the lipid metabolism, critical aortic stenosis
• Contraindications for Urapidil (Ebrantil®): aortic coarctation, arterio-venous shunt, breastfeeding period
• Patients with pre-existing disability and legal representative
• Patients participating in a interventional clinical trial within the last 30 days before Start of Treatment

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

clevidipine; urapidil

Study Officials

• Emanuela Keller, MD Prof

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: After admission to the ICU the patients presenting with primary intracerebral hemorrhage are evaluated for enrollment. If systolic blood pressure is higher than 160 mmHg or \<160 mmHg under intravenous antihypertensive drug, started less than 3 h before randomizsation, the patient will be randomized in one of the two study groups and intravenous therapy with Cleviprex® or Ebrantil® will start immediately. Data of systemic haemodynamics will be collected continuously by online monitoring, starting at baseline and ending after 24h. If the target values are not attained within 30 minutes, the investigators can add or switch to alternative antihypertensive drugs of their choice. 24h after initiation of Cleviprex® or Ebrantil®, all patients receive Cardene® (standard care in daily clinical routine) for another 24h followed by orally administered antihypertensive medication.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 3, 2017
• Study Start: June 15, 2017
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)