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

• Status: Withdrawn
• Trial end date: 2021-05-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Clevidipine; Urapidil

Criteria

Inclusion Criteria:

• 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

• 18 to unlimited years of age

• Signed informed consent obtained

Exclusion Criteria:

• 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