A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT) (PROMPT)
Primary Purpose
Aortic Aneurysm, Aortic Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
clevidipine.
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm focused on measuring acute, aortic, emergencies, Aortic dissection
Eligibility 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
Sites / Locations
- The Methodist Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open label, non-randomized, pilot study
Arm 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.
Outcomes
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.
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.
Full Information
NCT ID
NCT01033370
First Posted
December 15, 2009
Last Updated
August 23, 2018
Sponsor
Asma Zainab, M.D.
Collaborators
The Medicines Company, The Methodist Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01033370
Brief Title
A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
Acronym
PROMPT
Official Title
A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Project lacked funding.
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asma Zainab, M.D.
Collaborators
The Medicines Company, The Methodist Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Aortic Disease
Keywords
acute, aortic, emergencies, Aortic dissection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label, non-randomized, pilot study
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
clevidipine.
Other Intervention Name(s)
CLEVIPREX® (clevidipine)
Intervention Description
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).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Masud, MD
Organizational Affiliation
The Methodist Hospital and The Methodist Hospital Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asma Zainab, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Incomplete data set due to early trial closure.
Citations:
Citation
Clevidipine Investigator's Brochure, 2009.
Results Reference
background
Citation
Cleviprex Prescribing Information, August 1, 2008
Results Reference
background
PubMed Identifier
18191301
Citation
Cheung AT, Hobson RW 2nd. Hypertension in vascular surgery: aortic dissection and carotid revascularization. Ann Emerg Med. 2008 Mar;51(3 Suppl):S28-33. doi: 10.1016/j.annemergmed.2007.11.011. Epub 2008 Jan 11. No abstract available.
Results Reference
background
PubMed Identifier
18556693
Citation
Kertai MD, Westerhout CM, Varga KS, Acsady G, Gal J. Dihydropiridine calcium-channel blockers and perioperative mortality in aortic aneurysm surgery. Br J Anaesth. 2008 Oct;101(4):458-65. doi: 10.1093/bja/aen173. Epub 2008 Jun 12.
Results Reference
background
PubMed Identifier
18603160
Citation
Golledge J, Eagle KA. Acute aortic dissection. Lancet. 2008 Jul 5;372(9632):55-66. doi: 10.1016/S0140-6736(08)60994-0.
Results Reference
background
PubMed Identifier
16492293
Citation
Khoynezhad A, Plestis KA. Managing emergency hypertension in aortic dissection and aortic aneurysm surgery. J Card Surg. 2006 Mar-Apr;21 Suppl 1:S3-7. doi: 10.1111/j.1540-8191.2006.00213.x.
Results Reference
background
PubMed Identifier
12970252
Citation
Suzuki T, Mehta RH, Ince H, Nagai R, Sakomura Y, Weber F, Sumiyoshi T, Bossone E, Trimarchi S, Cooper JV, Smith DE, Isselbacher EM, Eagle KA, Nienaber CA; International Registry of Aortic Dissection. Clinical profiles and outcomes of acute type B aortic dissection in the current era: lessons from the International Registry of Aortic Dissection (IRAD). Circulation. 2003 Sep 9;108 Suppl 1:II312-7. doi: 10.1161/01.cir.0000087386.07204.09.
Results Reference
background
PubMed Identifier
11790701
Citation
Mehta RH, Suzuki T, Hagan PG, Bossone E, Gilon D, Llovet A, Maroto LC, Cooper JV, Smith DE, Armstrong WF, Nienaber CA, Eagle KA; International Registry of Acute Aortic Dissection (IRAD) Investigators. Predicting death in patients with acute type a aortic dissection. Circulation. 2002 Jan 15;105(2):200-6. doi: 10.1161/hc0202.102246.
Results Reference
background
PubMed Identifier
11511117
Citation
Erbel R, Alfonso F, Boileau C, Dirsch O, Eber B, Haverich A, Rakowski H, Struyven J, Radegran K, Sechtem U, Taylor J, Zollikofer C, Klein WW, Mulder B, Providencia LA; Task Force on Aortic Dissection, European Society of Cardiology. Diagnosis and management of aortic dissection. Eur Heart J. 2001 Sep;22(18):1642-81. doi: 10.1053/euhj.2001.2782. No abstract available.
Results Reference
background
PubMed Identifier
10685714
Citation
Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, Evangelista A, Fattori R, Suzuki T, Oh JK, Moore AG, Malouf JF, Pape LA, Gaca C, Sechtem U, Lenferink S, Deutsch HJ, Diedrichs H, Marcos y Robles J, Llovet A, Gilon D, Das SK, Armstrong WF, Deeb GM, Eagle KA. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000 Feb 16;283(7):897-903. doi: 10.1001/jama.283.7.897.
Results Reference
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A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
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