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

NCT01033370 | Terminated Phase 4

• 2 other identifiers: Pro00003478IRB(2)0809-0120
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Aneurysm; Aortic Disease

Keywords

acute; aortic; emergencies; Aortic dissection

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Hour

Secondary Outcomes (1)

• 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.

  48 Hours

Study Arms (1)

Open label, non-randomized, pilot study

OTHER

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.

Interventions

clevidipine. DRUG

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).

Also known as: CLEVIPREX® (clevidipine)

Open label, non-randomized, pilot study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asma Zainab, M.D.: lead
• The Medicines Company: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (10)

• Clevidipine Investigator's Brochure, 2009.

  BACKGROUND

• Cleviprex Prescribing Information, August 1, 2008

  BACKGROUND

• 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.

  PMID: 18191301 BACKGROUND

• 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.

  PMID: 18556693 BACKGROUND

• Golledge J, Eagle KA. Acute aortic dissection. Lancet. 2008 Jul 5;372(9632):55-66. doi: 10.1016/S0140-6736(08)60994-0.

  PMID: 18603160 BACKGROUND

• 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.

  PMID: 16492293 BACKGROUND

• 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.

  PMID: 12970252 BACKGROUND

• 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.

  PMID: 11790701 BACKGROUND

• 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.

  PMID: 11511117 BACKGROUND

• 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.

  PMID: 10685714 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Diseases; Emergencies; Aortic Dissection

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Faisal Masud, MD

  The Methodist Hospital and The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Asma Zainab, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)