StrokePCATNCT04553237
Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Stroke is a significant cause of death and disability in France and internationally. The incidence of stroke increases with age, equal for both sexes. Of all strokes, 50% of cases occur in patients over 75 years of age. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Stroke
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2020to 26 Apr 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients treated for stroke in the neurology department within the Groupe Hospitalier Paris Saint Joseph, between January 01, 2017 and December 31, 2019, i.e. 122 patients.
Who may be able to join
- Patient over 70 years old
- Patient treated in the neurology department of Paris Saint-Joseph hospital for a stroke between 2017 and 2019
- Patient treated by thrombolysis less than 4:30 after the onset of symptoms and / or by mechanical thrombectomy less than 24 hours.
- French-speaking patient
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of their data for this research
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is a significant cause of death and disability in France and internationally. The incidence of stroke increases with age, equal for both sexes. Of all strokes, 50% of cases occur in patients over 75 years of age. This advanced age leads to a high risk of mortality, long hospitalization, causing neurological sequelae in most cases.
Neurological handicap in the elderly is due to a high rate of comorbidity, reduced neuronal plasticity, nutritional status, and the short time to convert the penumbra area to ischemia.
Read more
Currently the standard treatment for the acute phase of HF is thrombolysis or thrombectomy.
The principle of thrombolysis is based on the use of a thrombolytic drug (Actylise®). It is a tissue plasminogen activator (t-PA) that will cause lysis and dissolution of clots blocking the artery. Thrombolysis is recommended until 4:30 a.m. after the onset of symptoms in the absence of contraindication.
Mechanical thrombectomy consists of removing the blood clot by introducing a probe into the artery having a proximal carotid or sylvic occlusion in its M1 portion or in the vertebro-basilar territory of an indeterminate schedule of less than 24 hours or determined from 6 hours to 24 hours having a radio-clinical mismatch, according to the DAWN study. The results of this study were analyzed according to age, NIHSS score and lesion volume on perfusion scanner or MRI (RAPID software). The interim analysis at 31 months on 206 randomized patients (107 thrombectomies versus 99 medical treatments alone) showed a clear superiority of the thrombectomy, leading to the premature end of the study, over the handicap at 3 months with more than 35 % of independent patients.
In most of the randomized studies, patients over 90 years of age have been excluded or are under-represented. This lack of data therefore does not make it possible to determine the effectiveness of thrombolysis or thrombectomy treatments in these patients.
A recent meta-analysis has shown that the functional recovery in these patients treated by thrombectomy is superior to those of the same age without thrombectomies. According to American studies, the advanced age of a patient is not a contraindication to this treatment.
Patients affected by a cerebral infarction represent 40 to 50% of hospitalizations in the neurology department of the Groupe Hospitalier Paris Saint-Joseph. In the intensive care of the neuro-vascular unit, the patient is received as quickly as possible to decide whether he can benefit from an extreme emergency treatment (intravenous thrombolysis or thrombectomy).
The present study should show that the clinical course after treatment in patients over 90 years of age is substantially comparable to younger patients, and that age is not a contraindication to treatment in the acute phase of stroke in the elderly.
- Conditions
- Stroke
- Medical subject headings
- 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 |
|---|---|---|
| Patients over 90 years old | Not described | |
| Patients between 70 and 89 years of age. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of stroke between two groups of patients.
This outcome corresponds to the comparaison of functional recovery at D90 after a stroke as measured by the Modified Rankin scale for measuring the degree of disability or dependence in the daily activities of patients.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Day 90
Secondary outcomes (3)
Symptomatic hemorrhagic changes
This outcome corresponds to the rate of patients with hemorrhagic transformation.
Measured: Day 90
Intra-hospital mortality
This outcome corresponds to the rate of patients with in-hospital mortality.
Measured: Day 90
Other complications
This outcome corresponds to the rate of patients presenting others complications during hospitalisation.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start11 Sep 2020
- Primary completion31 Mar 2021
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IOANA BABICIU, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553237
- Sponsor's protocol ID
- PCAT
- Acronym
- PCAT
- Status last verified
- Apr 2023
- First submitted
- 11 Sep 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murphy SL, Xu J, Kochanek KD, Curtin SC, Arias E. Deaths: Final Data for 2015. Natl Vital Stat Rep. 2017 Nov;66(6):1-75.
PubMed 29235985Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
PubMed 29367334GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
PubMed 27733282Saposnik G, Cote R, Phillips S, Gubitz G, Bayer N, Minuk J, Black S; Stroke Outcome Research Canada (SORCan) Working Group. Stroke outcome in those over 80: a multicenter cohort study across Canada. Stroke. 2008 Aug;39(8):2310-7. doi: 10.1161/STROKEAHA.107.511402. Epub 2008 Jun 12.
PubMed 18556583Castonguay AC, Zaidat OO, Novakovic R, Nguyen TN, Taqi MA, Gupta R, Sun CH, Martin C, Holloway WE, Mueller-Kronast N, E English J, Linfante I, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Abraham MG, Janardhan V, Shaltoni H, Yoo AJ, Abou-Chebl A, Chen PR, Britz GW, Kaushal R, Nanda A, A Issa M, Nogueira RG. Influence of age on clinical and revascularization outcomes in the North American Solitaire Stent-Retriever Acute Stroke Registry. Stroke. 2014 Dec;45(12):3631-6. doi: 10.1161/STROKEAHA.114.006487. Epub 2014 Oct 30.
PubMed 25358699Chandra RV, Leslie-Mazwi TM, Oh DC, Chaudhry ZA, Mehta BP, Rost NS, Rabinov JD, Hirsch JA, Gonzalez RG, Schwamm LH, Yoo AJ. Elderly patients are at higher risk for poor outcomes after intra-arterial therapy. Stroke. 2012 Sep;43(9):2356-61. doi: 10.1161/STROKEAHA.112.650713. Epub 2012 Jun 28.
PubMed 22744644Sharma JC, Fletcher S, Vassallo M. Strokes in the elderly - higher acute and 3-month mortality - an explanation. Cerebrovasc Dis. 1999 Jan-Feb;9(1):2-9. doi: 10.1159/000015889.
PubMed 9873157Sharobeam A, Cordato DJ, Manning N, Cheung A, Wenderoth J, Cappelen-Smith C. Functional Outcomes at 90 Days in Octogenarians Undergoing Thrombectomy for Acute Ischemic Stroke: A Prospective Cohort Study and Meta-Analysis. Front Neurol. 2019 Mar 20;10:254. doi: 10.3389/fneur.2019.00254. eCollection 2019.
PubMed 30949120To CY, Rajamand S, Mehra R, Falatko S, Badr Y, Richards B, Qahwash O, Fessler RD. Outcome of mechanical thrombectomy in the very elderly for the treatment of acute ischemic stroke: the real world experience. Acta Radiol Open. 2015 Sep 10;4(9):2058460115599423. doi: 10.1177/2058460115599423. eCollection 2015 Sep.
PubMed 26445678
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT04553237
- Acronym / sponsor ID
- PCAT / PCAT
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 17 Sep 2020 (actual)
- 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.
Stroke is a significant cause of death and disability in France and internationally. The incidence of stroke increases with age, equal for both sexes. Of all strokes, 50% of cases occur in patients over 75 years of age. This advanced age leads to a high risk of mortality, long hospitalization, causing neurological sequelae in most cases.
Neurological handicap in the elderly is due to a high rate of comorbidity, reduced neuronal plasticity, nutritional status, and the short time to convert the penumbra area to ischemia.
Currently the standard treatment for the acute phase of HF is thrombolysis or thrombectomy.
The principle of thrombolysis is based on the use of a thrombolytic drug (Actylise®). It is a tissue plasminogen activator (t-PA) that will cause lysis and dissolution of clots blocking the artery. Thrombolysis is recommended until 4:30 a.m. after the onset of symptoms in the absence of contraindication.
Mechanical thrombectomy consists of removing the blood clot by introducing a probe into the artery having a proximal carotid or sylvic occlusion in its M1 portion or in the vertebro-basilar territory of an indeterminate schedule of less than 24 hours or determined from 6 hours to 24 hours having a radio-clinical mismatch, according to the DAWN study. The results of this study were analyzed according to age, NIHSS score and lesion volume on perfusion scanner or MRI (RAPID software). The interim analysis at 31 months on 206 randomized patients (107 thrombectomies versus 99 medical treatments alone) showed a clear superiority of the thrombectomy, leading to the premature end of the study, over the handicap at 3 months with more than 35 % of independent patients.
In most of the randomized studies, patients over 90 years of age have been excluded or are under-represented. This lack of data therefore does not make it possible to determine the effectiveness of thrombolysis or thrombectomy treatments in these patients.
A recent meta-analysis has shown that the functional recovery in these patients treated by thrombectomy is superior to those of the same age without thrombectomies. According to American studies, the advanced age of a patient is not a contraindication to this treatment.
Patients affected by a cerebral infarction represent 40 to 50% of hospitalizations in the neurology department of the Groupe Hospitalier Paris Saint-Joseph. In the intensive care of the neuro-vascular unit, the patient is received as quickly as possible to decide whether he can benefit from an extreme emergency treatment (intravenous thrombolysis or thrombectomy).
The present study should show that the clinical course after treatment in patients over 90 years of age is substantially comparable to younger patients, and that age is not a contraindication to treatment in the acute phase of stroke in the elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients over 90 years old | – | – |
| Patients between 70 and 89 years of age. | – | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients treated for stroke in the neurology department within the Groupe Hospitalier Paris Saint Joseph, between January 01, 2017 and December 31, 2019, i.e. 122 patients.
Key inclusion criteria (4 listed)
- Patient over 70 years old
- Patient treated in the neurology department of Paris Saint-Joseph hospital for a stroke between 2017 and 2019
- Patient treated by thrombolysis less than 4:30 after the onset of symptoms and / or by mechanical thrombectomy less than 24 hours.
- French-speaking patient
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of their data for this research
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
Management of stroke between two groups of patients.
Time frame: Day 90
This outcome corresponds to the comparaison of functional recovery at D90 after a stroke as measured by the Modified Rankin scale for measuring the degree of disability or dependence in the daily activities of patients. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
3 secondary outcomes
Symptomatic hemorrhagic changes
Time frame: Day 90
Intra-hospital mortality
Time frame: Day 90
Other complications
Time frame: Day 90
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 27 Apr 2023.
- Results publication: PubMed 29235985Murphy SL, Xu J, Kochanek KD, Curtin SC, Arias E. Deaths: Final Data for 2015. Natl Vital Stat Rep. 2017 Nov;66(6):1-75.
- Results publication: PubMed 29367334Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
- Results publication: PubMed 27733282GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
- Results publication: PubMed 18556583Saposnik G, Cote R, Phillips S, Gubitz G, Bayer N, Minuk J, Black S; Stroke Outcome Research Canada (SORCan) Working Group. Stroke outcome in those over 80: a multicenter cohort study across Canada. Stroke. 2008 Aug;39(8):2310-7. doi: 10.1161/STROKEAHA.107.511402. Epub 2008 Jun 12.
- Results publication: PubMed 25358699Castonguay AC, Zaidat OO, Novakovic R, Nguyen TN, Taqi MA, Gupta R, Sun CH, Martin C, Holloway WE, Mueller-Kronast N, E English J, Linfante I, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Abraham MG, Janardhan V, Shaltoni H, Yoo AJ, Abou-Chebl A, Chen PR, Britz GW, Kaushal R, Nanda A, A Issa M, Nogueira RG. Influence of age on clinical and revascularization outcomes in the North American Solitaire Stent-Retriever Acute Stroke Registry. Stroke. 2014 Dec;45(12):3631-6. doi: 10.1161/STROKEAHA.114.006487. Epub 2014 Oct 30.
- Results publication: PubMed 22744644Chandra RV, Leslie-Mazwi TM, Oh DC, Chaudhry ZA, Mehta BP, Rost NS, Rabinov JD, Hirsch JA, Gonzalez RG, Schwamm LH, Yoo AJ. Elderly patients are at higher risk for poor outcomes after intra-arterial therapy. Stroke. 2012 Sep;43(9):2356-61. doi: 10.1161/STROKEAHA.112.650713. Epub 2012 Jun 28.
- Results publication: PubMed 9873157Sharma JC, Fletcher S, Vassallo M. Strokes in the elderly - higher acute and 3-month mortality - an explanation. Cerebrovasc Dis. 1999 Jan-Feb;9(1):2-9. doi: 10.1159/000015889.
- Results publication: PubMed 30949120Sharobeam A, Cordato DJ, Manning N, Cheung A, Wenderoth J, Cappelen-Smith C. Functional Outcomes at 90 Days in Octogenarians Undergoing Thrombectomy for Acute Ischemic Stroke: A Prospective Cohort Study and Meta-Analysis. Front Neurol. 2019 Mar 20;10:254. doi: 10.3389/fneur.2019.00254. eCollection 2019.
- Results publication: PubMed 26445678To CY, Rajamand S, Mehra R, Falatko S, Badr Y, Richards B, Qahwash O, Fessler RD. Outcome of mechanical thrombectomy in the very elderly for the treatment of acute ischemic stroke: the real world experience. Acta Radiol Open. 2015 Sep 10;4(9):2058460115599423. doi: 10.1177/2058460115599423. eCollection 2015 Sep.
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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.
IOANA BABICIU, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 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 27 Apr 2023. 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 France. 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?
Management of stroke between two groups of patients. (time frame: Day 90). 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 NCT04553237, which also lists 9 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 Apr 2023.