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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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).

Detailed Summary:

This study will be a Phase IV, open label, non-randomized efficacy and safety pilot trial in patients with AAE and hypertension requiring parenteral antihypertensive therapy. For the purpose of this study hypertension is defined as SBP ≥120 mm Hg immediately prior to clevidipine administration.

Patients will be enrolled at the Methodist DeBakey Heart & Vascular Center in Houston, TX. Enrollment of approximately 30 patients is anticipated and enrollment will continue until this goal is met.

The study will include three separate periods: Screening Period, Treatment Period (up to 48 hours) and Follow-up Period (up to 7 days or hospital discharge, whichever occurs first) representing approximately a maximum of 7 days on study. Eligible patients will be enrolled to receive clevidipine IV antihypertensive treatment (study drug) in an open label manner.

Clevidipine will be infused at an initial rate of 2 mg/h (4 mL/hr) for the first 3 minutes. Thereafter, titration to higher infusion rates can be attempted as needed to obtain the target SBP goal < 120 mmHg. Titration to effect is to proceed by doubling the dose every 3 minutes, up to a maximum of 32 mg/h (64 mL/hr), until the SBP < 120 mmHg is attained.

If the desired BP lowering effect is not attained with study drug within 1 hour or not maintained thereafter, an alternative antihypertensive agent may be used, with or without stopping clevidipine IV antihypertensive infusion. The alternative agent should be used per institutional treatment practice. During the initial 1 hour of the treatment period, however, clevidipine IV antihypertensive treatment should be administered as monotherapy until 1 hour post initiation of study drug. The use of an alternative antihyper
Sponsor: The Methodist Hospital System

Current Primary Outcome: The primary objective of this pilot study is to evaluate the efficacy of an IV infusion of clevidipine as an antihypertensive for BP lowering in patients with AAE and elevated BP. [ Time Frame: 1 Hour ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary objectives of the study are to evaluate the safety of an IV infusion of clevidipine as an antihypertensive for BP lowering in patients with AAE and elevated BP. [ Time Frame: 48 Hours ]

Original Secondary Outcome: Same as current

Information By: The Methodist Hospital System

Dates:
Date Received: December 15, 2009
Date Started: November 2009
Date Completion:
Last Updated: March 15, 2016
Last Verified: March 2016