A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single center, non-randomized, open-label, pilot efficacy and safety study evaluating the ability of clevidipine IV antihypertensive to rapidly control elevated blood pressure (BP) in the setting of an acute aortic emergencies (aneurysm, dissection or other aortic disease).

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

Details

• Lead Sponsor: Asma Zainab, M.D.; The Methodist Hospital System
• Collaborators: The Medicines Company; The Methodist Hospital Research Institute
• Treatments: Clevidipine

Criteria

Inclusion Criteria:

• Age 18 years or older

• Diagnosis of AAE (aneurysm, dissection or other aortic disease)

• Baseline SBP (immediately prior to initiation of study drug) of ≥120 mm Hg

• Requires IV antihypertensive therapy to lower BP

• Written informed consent before initiation of any study related procedures

Exclusion Criteria:

• Intolerance or allergy to calcium channel blockers, soy or egg products

• Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with cardiac ischemia

• Cardiogenic shock

• Severe arrhythmia

• Severe aortic stenosis

• Positive pregnancy test, known pregnancy or breast feeding female

• Known liver failure, cirrhosis or pancreatitis

• Prior directives against advanced life support (no code status)

• Those, in the opinion of the participating physician, regarding as inappropriate for the study for any other medical reason