Peripheral Vascular DiseasePIVOTALNCT01897103
Platelet Activity in Vascular Surgery for Thrombosis and Bleeding
An observational study of Peripheral Vascular Disease and Peripheral Artery Disease, run by NYU Langone Health at 2 sites in United States.
Trial summary
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Peripheral Artery Disease, Carotid Stenosis
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Dec 2017
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population will be selected from the inpatient setting at NYU Medical Center and Bellevue Hospital as well as the outpatient setting in the Faculty Group Practice.
Who may be able to join
- Subjects undergoing non emergent vascular surgery
- Use of aspirin within 48 hours prior to surgery
- Age > 21 years of age
- Able and willing to provide written informed consent for the study
Who cannot join
- Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery
- Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours
- Thrombocytopenia (platelet count<100) or Thrombocytosis (platelet count>500),
- Anemia (hemoglobin<9),
- Severe kidney disease (CrCl<30ml/min),
- Any known hemorrhagic diathesis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hospital Center, South Manhattan Healthcare Network
New York, New York, 10016
New York University School Of Medicine
New York, New York, 10016
About this study
Official title: Platelet Activity in Vascular Surgery
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.
Read the detailed description
To describe platelet activity among PAD subjects undergoing vascular surgery.
To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.
To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
- Conditions
- Peripheral Vascular Disease, Peripheral Artery Disease, Carotid Stenosis, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Amputation, Wound
- Keywords
- Peripheral Artery Disease, Endarterectomy (Carotid), Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Amputation, Platelet Activity, Thrombin, Transcriptomics
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Carotid Stenosis, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Wounds and Injuries, Embolism and Thrombosis, Aortic Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Activity
The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.
Measured: two years
Secondary outcomes (1)
Perioperative Events
Thrombotic and Bleeding events
Measured: Two-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Berger, MD, MS, FAHA, FACC, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897103
- Sponsor's protocol ID
- 12-03123
- Acronym
- PIVOTAL
- Status last verified
- Dec 2017
- First submitted
- 8 Jul 2013
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012 Jul 24;126(4):491-500. doi: 10.1161/CIRCULATIONAHA.111.033886. No abstract available.
PubMed 22825411Berger JS, Becker RC, Kuhn C, Helms MJ, Ortel TL, Williams R. Hyperreactive platelet phenotypes: relationship to altered serotonin transporter number, transport kinetics and intrinsic response to adrenergic co-stimulation. Thromb Haemost. 2013 Jan;109(1):85-92. doi: 10.1160/TH12-03-0202. Epub 2012 Dec 6.
PubMed 23223800Chu SG, Becker RC, Berger PB, Bhatt DL, Eikelboom JW, Konkle B, Mohler ER, Reilly MP, Berger JS. Mean platelet volume as a predictor of cardiovascular risk: a systematic review and meta-analysis. J Thromb Haemost. 2010 Jan;8(1):148-56. doi: 10.1111/j.1538-7836.2009.03584.x. Epub 2009 Aug 19.
PubMed 19691485Eraso LH, Fukaya E, Mohler ER 3rd, Xie D, Sha D, Berger JS. Peripheral arterial disease, prevalence and cumulative risk factor profile analysis. Eur J Prev Cardiol. 2014 Jun;21(6):704-11. doi: 10.1177/2047487312452968. Epub 2012 Jun 27.
PubMed 22739687Sharma G, Berger JS. Platelet activity and cardiovascular risk in apparently healthy individuals: a review of the data. J Thromb Thrombolysis. 2011 Aug;32(2):201-8. doi: 10.1007/s11239-011-0590-9.
PubMed 21562837Dann R, Hadi T, Montenont E, Boytard L, Alebrahim D, Feinstein J, Allen N, Simon R, Barone K, Uryu K, Guo Y, Rockman C, Ramkhelawon B, Berger JS. Platelet-Derived MRP-14 Induces Monocyte Activation in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2018 Jan 2;71(1):53-65. doi: 10.1016/j.jacc.2017.10.072.
PubMed 29301628
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activity in Vascular Surgery
- ClinicalTrials.gov ID
- NCT01897103
- Acronym / sponsor ID
- PIVOTAL / 12-03123
- Conditions
- Peripheral Vascular Disease, Peripheral Artery Disease, Carotid Stenosis, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Amputation, Wound
- Keywords
- Peripheral Artery Disease, Endarterectomy (Carotid), Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Amputation, Platelet Activity, Thrombin, Transcriptomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jun 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Jul 2013 (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.
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.
Detailed description
To describe platelet activity among PAD subjects undergoing vascular surgery.
To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.
To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population will be selected from the inpatient setting at NYU Medical Center and Bellevue Hospital as well as the outpatient setting in the Faculty Group Practice.
Key inclusion criteria (4 listed)
- Subjects undergoing non emergent vascular surgery
- Use of aspirin within 48 hours prior to surgery
- Age > 21 years of age
- Able and willing to provide written informed consent for the study
Key exclusion criteria (6 listed)
- Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery
- Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours
- Thrombocytopenia (platelet count<100) or Thrombocytosis (platelet count>500),
- Anemia (hemoglobin<9),
- Severe kidney disease (CrCl<30ml/min),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet Activity
Time frame: two years
The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling.
1 secondary outcome
Perioperative Events
Time frame: Two-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Background: PubMed 22825411Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012 Jul 24;126(4):491-500. doi: 10.1161/CIRCULATIONAHA.111.033886. No abstract available.
- Background: PubMed 23223800Berger JS, Becker RC, Kuhn C, Helms MJ, Ortel TL, Williams R. Hyperreactive platelet phenotypes: relationship to altered serotonin transporter number, transport kinetics and intrinsic response to adrenergic co-stimulation. Thromb Haemost. 2013 Jan;109(1):85-92. doi: 10.1160/TH12-03-0202. Epub 2012 Dec 6.
- Background: PubMed 19691485Chu SG, Becker RC, Berger PB, Bhatt DL, Eikelboom JW, Konkle B, Mohler ER, Reilly MP, Berger JS. Mean platelet volume as a predictor of cardiovascular risk: a systematic review and meta-analysis. J Thromb Haemost. 2010 Jan;8(1):148-56. doi: 10.1111/j.1538-7836.2009.03584.x. Epub 2009 Aug 19.
- Background: PubMed 22739687Eraso LH, Fukaya E, Mohler ER 3rd, Xie D, Sha D, Berger JS. Peripheral arterial disease, prevalence and cumulative risk factor profile analysis. Eur J Prev Cardiol. 2014 Jun;21(6):704-11. doi: 10.1177/2047487312452968. Epub 2012 Jun 27.
- Background: PubMed 21562837Sharma G, Berger JS. Platelet activity and cardiovascular risk in apparently healthy individuals: a review of the data. J Thromb Thrombolysis. 2011 Aug;32(2):201-8. doi: 10.1007/s11239-011-0590-9.
- Derived from this study: PubMed 29301628Dann R, Hadi T, Montenont E, Boytard L, Alebrahim D, Feinstein J, Allen N, Simon R, Barone K, Uryu K, Guo Y, Rockman C, Ramkhelawon B, Berger JS. Platelet-Derived MRP-14 Induces Monocyte Activation in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2018 Jan 2;71(1):53-65. doi: 10.1016/j.jacc.2017.10.072.
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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.
Jeffrey S Berger, MD, MS, FAHA, FACC principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Peripheral Artery Disease, run by NYU Langone Health at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Platelet Activity (time frame: two years). 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 NCT01897103, which also lists 6 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 14 Dec 2017.