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

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ClinicalTrials.gov Identifier: NCT01033370
Recruitment Status : Terminated (Project lacked funding.)
First Posted : December 16, 2009
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
The Medicines Company
The Methodist Hospital Research Institute
Information provided by (Responsible Party):
Asma Zainab, M.D., The Methodist Hospital Research Institute

Study Description
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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).

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Aortic Disease Drug: clevidipine. Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
Study Start Date : November 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Clevidipine

Arms and Interventions
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Arm Intervention/treatment
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 Name: CLEVIPREX® (clevidipine)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033370


Locations
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United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Asma Zainab, M.D.
The Medicines Company
The Methodist Hospital Research Institute
Investigators
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Principal Investigator: Faisal Masud, MD The Methodist Hospital and The Methodist Hospital Research Institute
Principal Investigator: Asma Zainab, MD The Methodist Hospital Research Institute
More Information
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Publications:
Clevidipine Investigator's Brochure, 2009.
Cleviprex Prescribing Information, August 1, 2008

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Responsible Party: Asma Zainab, M.D., Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01033370    
Other Study ID Numbers: Pro00003478
IRB(2)0809-0120 ( Other Identifier: HMRI IRB )
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Incomplete data set due to early trial closure.
Keywords provided by Asma Zainab, M.D., The Methodist Hospital Research Institute:
acute
aortic
emergencies
Aortic dissection
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Diseases
Emergencies
Disease Attributes
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Clevidipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs