StrokeNCT00890812
Factor XI Levels in Acute Ischemic Stroke
An observational study of Stroke, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the utility of measuring coagulation factor activities in the setting of acute ischemic stroke, as potential markers of inherited thrombotic risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients presenting to the University of Utah Health Sciences Center Emergency Department.
Who may be able to join
- Those clinically diagnosed with acute ischemic stroke
- 18 years of age or greater
Who cannot join
- Those without clinical diagnosis of acute ischemic stroke will be included in the control group.
- Patients with hemorrhagic strokes
- Inpatients who are evaluated through the Brain Attack protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
The purpose of this study is to evaluate the utility of measuring coagulation factor activities in the setting of acute ischemic stroke, as potential markers of inherited thrombotic risk. The investigators will determine if relationships exist between coagulation factors, including factor VIII, factor IX, and factor XI and clinical diagnosis, classification, and outcome. The investigators will determine if any significant elevations of these factor activities are independent thrombotic risk factors.
Null Hypothesis: There is no statistical difference between coagulation factors, including factors VIII, IX, or XI activity levels in patients having acute ischemic stroke as compared to acute stroke mimics.
Read the detailed description
Increased factor XI levels have been associated with venous thromboembolic disease and acute myocardial infarction. However, checking factor XI levels is not currently indicated to assess individual thromboembolic risk. Factor XI is an important protease that links the extrinsic arm of the coagulation cascade with the intrinsic arm through dual activation by both factor XII and thrombin. Since thrombin is a downstream product of factor XI, a feedback loop is created that amplifies thrombin production and ultimately results formation of a stable fibrin clot. Sufficient thrombin generation via this pathway also contributes to activation of the Thrombin-Activatable Fibrinolysis Inhibitor (TAFI). Activated TAFI downregulates fibrinolysis and has been implicated as part of the association between elevated factor XI levels and venous thromboembolic disease. One study found that functional TAFI levels of > 120% increased the risk of ischemic stroke approximately 6-fold, however, the association between Factor XI and ischemic stroke has yet to be firmly established. We recently performed a preliminary retrospective analysis of 78 patients with stroke or transient ischemic attack (TIA) and found that patients with factor XI activity levels above the 95th percentile of an age and sex matched reference population had a relative risk of 5.3 for stroke or TIA. Factor XI measurements may be able to help identify thromboembolic disease, aiding in the determination of stroke etiology.
- Conditions
- Stroke
- Keywords
- Acute Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Factors VIII, IX and XI levels measured | Case group | |
| Non Stroke patients | This is the control group. This group represents patients who were initially evaluated for stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the relationship between elevated factors VIII, IX and XI and acute ischemic stroke as compared to other emergent events.
Measured: At time of incident stroke (baseline) and at early follow-up (30-60 Days post stroke).
Secondary outcomes (4)
To determine the relationship between elevated factors VIII, IX and XI and stroke subtype.
Measured: 30-60 Days post stroke
To determine if a relationship exists between elevated factors VIII, IX and XI and the clinical severity and stroke outcome.
Measured: 30-60 Days post stroke
To determine if factors VIII, IX and XI level are different in the acute phase of ischemic stroke relative to chronic phase.
Measured: 30-60 Days post stroke
To determine if a relationship exists between factors VIII, IX and XI levels and early stroke/TIA recurrence.
Measured: 30-60 Days post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Sheila B. Terry Memorial Research Fund
- Investigators
- Jennifer Majersik, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890812
- Sponsor's protocol ID
- 14363
- Other IDs
- ACC: 46499140, IRB: 00014363
- Status last verified
- Aug 2011
- First submitted
- 28 Apr 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chandler WL, Rodgers GM, Sprouse JT, Thompson AR. Elevated hemostatic factor levels as potential risk factors for thrombosis. Arch Pathol Lab Med. 2002 Nov;126(11):1405-14. doi: 10.5858/2002-126-1405-EHFLAP.
PubMed 12421150Meijers JC, Tekelenburg WL, Bouma BN, Bertina RM, Rosendaal FR. High levels of coagulation factor XI as a risk factor for venous thrombosis. N Engl J Med. 2000 Mar 9;342(10):696-701. doi: 10.1056/NEJM200003093421004.
PubMed 10706899Minnema MC, Peters RJ, de Winter R, Lubbers YP, Barzegar S, Bauer KA, Rosenberg RD, Hack CE, ten Cate H. Activation of clotting factors XI and IX in patients with acute myocardial infarction. Arterioscler Thromb Vasc Biol. 2000 Nov;20(11):2489-93. doi: 10.1161/01.atv.20.11.2489.
PubMed 11073857Murakami T, Komiyama Y, Masuda M, Karakawa M, Iwasaka T, Takahashi H. Evaluation of factor XIa-alpha 1-antitrypsin in plasma, a contact phase-activated coagulation factor-inhibitor complex, in patients with coronary artery disease. Arterioscler Thromb Vasc Biol. 1995 Aug;15(8):1107-13. doi: 10.1161/01.atv.15.8.1107.
PubMed 7627703Santamaria A, Oliver A, Borrell M, Mateo J, Belvis R, Marti-Fabregas J, Ortin R, Tirado I, Souto JC, Fontcuberta J. Risk of ischemic stroke associated with functional thrombin-activatable fibrinolysis inhibitor plasma levels. Stroke. 2003 Oct;34(10):2387-91. doi: 10.1161/01.STR.0000088642.07691.15. Epub 2003 Aug 28.
PubMed 12947154Yang DT, Flanders MM, Kim H, Rodgers GM. Elevated factor XI activity levels are associated with an increased odds ratio for cerebrovascular events. Am J Clin Pathol. 2006 Sep;126(3):411-5. doi: 10.1309/QC259F09UNMKVP0R.
PubMed 16880142Salomon O, Steinberg DM, Koren-Morag N, Tanne D, Seligsohn U. Reduced incidence of ischemic stroke in patients with severe factor XI deficiency. Blood. 2008 Apr 15;111(8):4113-7. doi: 10.1182/blood-2007-10-120139. Epub 2008 Feb 11.
PubMed 18268095
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factor XI Levels in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00890812
- Acronym / sponsor ID
- 14363
- Conditions
- Stroke
- Keywords
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Sheila B. Terry Memorial Research Fund
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Apr 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.
The purpose of this study is to evaluate the utility of measuring coagulation factor activities in the setting of acute ischemic stroke, as potential markers of inherited thrombotic risk. The investigators will determine if relationships exist between coagulation factors, including factor VIII, factor IX, and factor XI and clinical diagnosis, classification, and outcome. The investigators will determine if any significant elevations of these factor activities are independent thrombotic risk factors.
Null Hypothesis: There is no statistical difference between coagulation factors, including factors VIII, IX, or XI activity levels in patients having acute ischemic stroke as compared to acute stroke mimics.
Detailed description
Increased factor XI levels have been associated with venous thromboembolic disease and acute myocardial infarction. However, checking factor XI levels is not currently indicated to assess individual thromboembolic risk. Factor XI is an important protease that links the extrinsic arm of the coagulation cascade with the intrinsic arm through dual activation by both factor XII and thrombin. Since thrombin is a downstream product of factor XI, a feedback loop is created that amplifies thrombin production and ultimately results formation of a stable fibrin clot. Sufficient thrombin generation via this pathway also contributes to activation of the Thrombin-Activatable Fibrinolysis Inhibitor (TAFI). Activated TAFI downregulates fibrinolysis and has been implicated as part of the association between elevated factor XI levels and venous thromboembolic disease. One study found that functional TAFI levels of > 120% increased the risk of ischemic stroke approximately 6-fold, however, the association between Factor XI and ischemic stroke has yet to be firmly established. We recently performed a preliminary retrospective analysis of 78 patients with stroke or transient ischemic attack (TIA) and found that patients with factor XI activity levels above the 95th percentile of an age and sex matched reference population had a relative risk of 5.3 for stroke or TIA. Factor XI measurements may be able to help identify thromboembolic disease, aiding in the determination of stroke etiology.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Factors VIII, IX and XI levels measured | – | –Case group |
| Non Stroke patients | – | –This is the control group. This group represents patients who were initially evaluated for stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presenting to the University of Utah Health Sciences Center Emergency Department.
Key inclusion criteria (2 listed)
- Those clinically diagnosed with acute ischemic stroke
- 18 years of age or greater
Key exclusion criteria (3 listed)
- Those without clinical diagnosis of acute ischemic stroke will be included in the control group.
- Patients with hemorrhagic strokes
- Inpatients who are evaluated through the Brain Attack protocol
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
To determine the relationship between elevated factors VIII, IX and XI and acute ischemic stroke as compared to other emergent events.
Time frame: At time of incident stroke (baseline) and at early follow-up (30-60 Days post stroke).
4 secondary outcomes
To determine the relationship between elevated factors VIII, IX and XI and stroke subtype.
Time frame: 30-60 Days post stroke
To determine if a relationship exists between elevated factors VIII, IX and XI and the clinical severity and stroke outcome.
Time frame: 30-60 Days post stroke
To determine if factors VIII, IX and XI level are different in the acute phase of ischemic stroke relative to chronic phase.
Time frame: 30-60 Days post stroke
To determine if a relationship exists between factors VIII, IX and XI levels and early stroke/TIA recurrence.
Time frame: 30-60 Days post stroke
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 4 Aug 2011.
- Results publication: PubMed 12421150Chandler WL, Rodgers GM, Sprouse JT, Thompson AR. Elevated hemostatic factor levels as potential risk factors for thrombosis. Arch Pathol Lab Med. 2002 Nov;126(11):1405-14. doi: 10.5858/2002-126-1405-EHFLAP.
- Results publication: PubMed 10706899Meijers JC, Tekelenburg WL, Bouma BN, Bertina RM, Rosendaal FR. High levels of coagulation factor XI as a risk factor for venous thrombosis. N Engl J Med. 2000 Mar 9;342(10):696-701. doi: 10.1056/NEJM200003093421004.
- Results publication: PubMed 11073857Minnema MC, Peters RJ, de Winter R, Lubbers YP, Barzegar S, Bauer KA, Rosenberg RD, Hack CE, ten Cate H. Activation of clotting factors XI and IX in patients with acute myocardial infarction. Arterioscler Thromb Vasc Biol. 2000 Nov;20(11):2489-93. doi: 10.1161/01.atv.20.11.2489.
- Results publication: PubMed 7627703Murakami T, Komiyama Y, Masuda M, Karakawa M, Iwasaka T, Takahashi H. Evaluation of factor XIa-alpha 1-antitrypsin in plasma, a contact phase-activated coagulation factor-inhibitor complex, in patients with coronary artery disease. Arterioscler Thromb Vasc Biol. 1995 Aug;15(8):1107-13. doi: 10.1161/01.atv.15.8.1107.
- Results publication: PubMed 12947154Santamaria A, Oliver A, Borrell M, Mateo J, Belvis R, Marti-Fabregas J, Ortin R, Tirado I, Souto JC, Fontcuberta J. Risk of ischemic stroke associated with functional thrombin-activatable fibrinolysis inhibitor plasma levels. Stroke. 2003 Oct;34(10):2387-91. doi: 10.1161/01.STR.0000088642.07691.15. Epub 2003 Aug 28.
- Results publication: PubMed 16880142Yang DT, Flanders MM, Kim H, Rodgers GM. Elevated factor XI activity levels are associated with an increased odds ratio for cerebrovascular events. Am J Clin Pathol. 2006 Sep;126(3):411-5. doi: 10.1309/QC259F09UNMKVP0R.
- Results publication: PubMed 18268095Salomon O, Steinberg DM, Koren-Morag N, Tanne D, Seligsohn U. Reduced incidence of ischemic stroke in patients with severe factor XI deficiency. Blood. 2008 Apr 15;111(8):4113-7. doi: 10.1182/blood-2007-10-120139. Epub 2008 Feb 11.
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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.
Jennifer Majersik, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Utah 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 2 inclusion and 3 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 4 Aug 2011. 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.
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?
To determine the relationship between elevated factors VIII, IX and XI and acute ischemic stroke as compared to other emergent events. (time frame: At time of incident stroke (baseline) and at early follow-up (30-60 Days post stroke).). 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 NCT00890812, which also lists 7 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 4 Aug 2011.