A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/29/2018 |
| Start Date: | November 2009 |
| End Date: | August 2012 |
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).
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).
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.
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.
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
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