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Clinical Trial Details


Research Study Summary

A Phase 4 clinical study for patients with Aortic Aneurysm or Aortic Disease

Research Study Title

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


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).

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Both Male and Female


18 and up

Overall Status


Lead Sponsor

The Methodist Hospital System


21 Months

Facility Type



Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
United States Texas Houston 77030 The Methodist Hospital
Glenda Santua

Mark Davies, MD

Iqbal Ratnani, MD

Hany Samir, MD

Asma Zainab, MD
Principal Investigator

Faisal Masud, MD


Glenda Santua

NCT ID: NCT01033370

Date Last Changed: July 26, 2011

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