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

August 23, 2018 updated by: Asma Zainab, M.D.
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 antihypertensive agent(s) is discouraged and limited to where medically necessary to maintain patient safety.

Clevidipine IV antihypertensive infusion may continue for a maximum of 48 hours. However, if medically warranted, clevidipine treatment may continue beyond 48 hours at the investigator's discretion.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open label, non-randomized, pilot study
All subjects who provide consent for trial participation with an acute aortic emergency and elevated BP (systolic blood pressure [SBP] ≥120 mm Hg) requiring IV antihypertensive therapy for up to 48 hours will be administered an infusion of clevidipine to evaluate the efficacy and safety of the IV drug.
Drug: clevidipine.
Clevidipine administered per IV infusion, starting dose of 2 mg/h (4 mL/hr) for 3 minutes & titrated to the desired BP lowering effect to SBP goal of < 120 mmHg, max infusion rate may not exceed 32 mg/h (64 mL/hr).
Other Names:
  • CLEVIPREX® (clevidipine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 Hour

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asma Zainab, M.D.

Collaborators

The Medicines Company
The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Faisal Masud, MD, The Methodist Hospital and The Methodist Hospital Research Institute
  • Principal Investigator: Asma Zainab, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00003478
  • IRB(2)0809-0120 (Other Identifier: HMRI IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Incomplete data set due to early trial closure.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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