Aortic AneurysmPhase 4PROMPTNCT01033370
A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
A Phase 4 study testing clevidipine. in people with Aortic Aneurysm and Aortic Disease, run by Asma Zainab, M.D. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Disease
- What is being tested?
- clevidipine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Aortic Aneurysm, Aortic Disease
- Being tested
- clevidipine.
- Keywords
- acute, aortic, emergencies, Aortic dissection
- Medical subject headings
- Aortic Aneurysm, Aortic Diseases, Emergencies, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clevidipine.Drug
Also called CLEVIPREX® (clevidipine)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: clevidipine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Project lacked funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asma Zainab, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- The Medicines Company, The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Asma Zainab, M.D., The Methodist Hospital Research Institute
- Investigators
- Faisal Masud, MD, Principal investigator, The Methodist Hospital and The Methodist Hospital Research InstituteAsma Zainab, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033370
- Sponsor's protocol ID
- Pro00003478
- Other IDs
- IRB(2)0809-0120
- Acronym
- PROMPT
- Status last verified
- Aug 2018
- First submitted
- 15 Dec 2009
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Incomplete data set due to early trial closure.
Publications
Clevidipine Investigator's Brochure, 2009.
Cleviprex Prescribing Information, August 1, 2008
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.
PubMed 18191301Kertai 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.
PubMed 18556693Golledge J, Eagle KA. Acute aortic dissection. Lancet. 2008 Jul 5;372(9632):55-66. doi: 10.1016/S0140-6736(08)60994-0.
PubMed 18603160Khoynezhad 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.
PubMed 16492293Suzuki 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.
PubMed 12970252Mehta 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.
PubMed 11790701Erbel 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.
PubMed 11511117Hagan 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.
PubMed 10685714
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)
- ClinicalTrials.gov ID
- NCT01033370
- Acronym / sponsor ID
- PROMPT / Pro00003478
- Conditions
- Aortic Aneurysm, Aortic Disease
- Keywords
- acute, aortic, emergencies, Aortic dissection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project lacked funding.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Asma Zainab, M.D.University, hospital or other
- Collaborators
- The Medicines Company, The Methodist Hospital Research Institute
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label, non-randomized, pilot study | Other | Drug: clevidipine.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clevidipine.Also: CLEVIPREX® (clevidipine)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). | Drug | Open label, non-randomized, pilot study |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Project lacked funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- BackgroundClevidipine Investigator's Brochure, 2009.
- BackgroundCleviprex Prescribing Information, August 1, 2008
- Background: PubMed 18191301Cheung 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.
- Background: PubMed 18556693Kertai 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.
- Background: PubMed 18603160Golledge J, Eagle KA. Acute aortic dissection. Lancet. 2008 Jul 5;372(9632):55-66. doi: 10.1016/S0140-6736(08)60994-0.
- Background: PubMed 16492293Khoynezhad 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.
- Background: PubMed 12970252Suzuki 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.
- Background: PubMed 11790701Mehta 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.
- Background: PubMed 11511117Erbel 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.
- Background: PubMed 10685714Hagan 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.
- Individual participant dataSharing planned: No. Incomplete data set due to early trial closure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal Masud, MD principal investigator
The Methodist Hospital and The Methodist Hospital Research Institute
Asma Zainab, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clevidipine. in people with Aortic Aneurysm and Aortic Disease, run by Asma Zainab, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Project lacked funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033370, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.