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

Asma Zainab, M.D.

Status and phase: Terminated; Phase 4

Conditions: Aortic Aneurysm; Aortic Disease

Treatments: Drug: clevidipine.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01033370

Pro00003478

IRB(2)0809-0120 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Open label, non-randomized, pilot study

Other group

Description:

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.

Treatment:

Drug: clevidipine.