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Clinical Trial Details

Overview

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)

Purpose

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).

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

The Methodist Hospital System

Duration

21 Months

Facility Type

N/A

Eligibility

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
GKSantua@tmhs.org

Mark Davies, MD
Sub-Investigator

Iqbal Ratnani, MD
Sub-Investigator

Hany Samir, MD
Sub-Investigator

Asma Zainab, MD
Principal Investigator

Faisal Masud, MD
Sub-Investigator

Contact

Glenda Santua
713-441-3914
E-mail:

NCT ID: NCT01033370

Date Last Changed: July 26, 2011

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