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

Stopped early · Phase 4

Conditions studied: Aortic Aneurysm, Aortic Disease

In brief

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).

Key facts

Study ID

NCT01033370

Run by

Asma Zainab, M.D.

People needed

5

Starts

2009-11-01

Expected to finish

2012-08-01

Last updated by the study team

2018-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.