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

This study has been terminated.
(Project lacked funding.)
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01033370
First received: December 15, 2009
Last updated: March 15, 2016
Last verified: March 2016
  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).

Condition Intervention Phase
Aortic Aneurysm
Aortic Disease
Drug: clevidipine.
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: November 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033370

Locations
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
The Medicines Company
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
  More Information

Publications:
Clevidipine Investigator's Brochure, 2009.
Cleviprex Prescribing Information, August 1, 2008

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01033370     History of Changes
Other Study ID Numbers: Pro00003478  IRB(2)0809-0120 
Study First Received: December 15, 2009
Last Updated: March 15, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Incomplete data set due to early trial closure.

Keywords provided by The Methodist Hospital System:
acute
aortic
emergencies
Aortic dissection

Additional relevant MeSH terms:
Emergencies
Aneurysm
Aortic Aneurysm
Aortic Diseases
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Clevidipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016