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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by The Methodist Hospital System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Medicines Company
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01033370
First received: December 15, 2009
Last updated: July 26, 2011
Last verified: July 2011
  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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: clevidipine.
    For the purposes of this study, clevidipine is to be administered via IV infusion at a starting dose of 2 mg/h (4 mL/hr) for 3 minutes and thereafter titrated to the desired BP lowering effect to achieve the SBP goal of < 120 mmHg. At the discretion of the investigator, it is recommended that clevidipine be titrated, as tolerated by the patient, in doubling increments every 3 minutes in order to achieve the desired BP lowering effect. The maximum infusion rate may not exceed 32 mg/h (64 mL/hr). Clevidipine infusion may be titrated upwards and downwards, keeping in mind that it has a very rapid onset of effect on BP, i.e., 2-4 minutes. Although the clevidipine infusion rate may be decreased at the discretion of the investigator in order to achieve/maintain the SBP goal, the minimum infusion rate should not be lower than 1 mg/h (2 mL/hr). Clevidipine infusion may be terminated at any time for a safety reason or at the investigator's discretion.
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
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

Contacts
Contact: Glenda Santua 713-441-3914 gksantua@tmhs.org

Locations
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Glenda Santua       GKSantua@tmhs.org   
Sub-Investigator: Mark Davies, MD         
Sub-Investigator: Iqbal Ratnani, MD         
Sub-Investigator: Hany Samir, MD         
Principal Investigator: Asma Zainab, MD         
Sub-Investigator: Faisal Masud, MD         
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
  More Information

Publications:
Golledge J, Eagle K. Acute aortic dissection. Lancet. 2008;372:55-66.
Erbel R, Alfonso F, Boileau C, et al. Task force on aortic dissection, European society of cardiology. Diagnosis and management of aortic dissection. Eur Heart J. 2001;22:1642-1681.

Responsible Party: Asma Zainab, MD, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01033370     History of Changes
Other Study ID Numbers: IRB(2)0809-0120
Study First Received: December 15, 2009
Last Updated: July 26, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014