Carotid StenosisCASCOM-PilotNCT04947046
Carotid Stenosis Management During COVID-19 Era - Pilot Study
An observational study of Carotid Stenosis and Carotid Artery Diseases, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2020to 1 Mar 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced (50-99% or 60-99%, respectively) carotid stenosis in symptomatic patients who do not undergo CEA or CAS or similar procedures for any reason, including lack of resources caused by the coronavirus pandemic, situations of unproven procedural benefit, anticipated procedural futility or net harm or patient refusal. Hence, the investigators will study patients for whom carotid procedures are not possible or considered unethical.
Who may be able to join
- Patients who's life expectancy is > 3 years despite age > 80 years.
- Patients who have not been timely offered CEA under COVID-19 (eg women / men with 50-69%), which can only be operated on after 4 weeks after their last symptom.
- Patients with modified ranking scale (mRs) > 3, which during rehabilitation improve and move to mRs < 3.
- High risk cardio pulmonary patients (ejection fraction < 20% - severe chronic obstructive pulmonary disease) that is not estimated to withstand surgery or has a technically demanding neck anatomy with a life expectancy > 3 years.
- Patients who score below 15% on Carotid Artery Risk score (CAR-score) (5-year stroke risk is < 15% with only best medical treatment) for ipsilateral stroke.
- Patients with newly discovered cancer and stroke who require a cancer disease investigation or treatment and have a life expectancy of more than 3 years.
Show all 15Show fewer
- 50-69% and 70-99% narrowing (stenosis) of the ipsilateral internal carotid artery origin (and/or carotid bulb) verified by duplex ultrasound, CT-angio or MR-angio.
- Presence of an ipsilateral non-disabling (non-severe) stroke (mRs < 3, ie mRs of 1 or 2) or transient ischaemic attack (TIA) in the previous four (1,2) to six months (1,3) and ipsilateral 50-99% carotid stenosis measured using NASCET criteria.
- Index symptoms attributable to atherosclerotic carotid disease (not due to fibromuscular dysplasia, aneurysm or tumour).
- Absence of severe stroke on either side resulting in no useful function in the affected arterial territory
- Absence of a known more severe ipsilateral intracranial infarct site of arterial narrowing
- Absence of previous ipsilateral CEA or angioplasty/stenting or other carotid revascularisation procedure.
- Mentally competent and consenting to participate in CASCOM Pilot Study in minimum 3 years.
- Life expectancy > 3 years including the absence of kidney, liver or lung failure or advanced cancer or advanced dementia, major/severe stroke (mRs > 3), perceived significant frailty or unsuitable arterial anatomy. Risk classification level of IV or higher as well as CAR-score.
- Absence of cardiac valvular or rhythm disorder likely associated with cardioembolism. In the absence of more specific published information the investigators will exclude patients with newly discovered atrial fibrillation and prosthetic heart valves from the primary analyses of symptomatic patients.
Who cannot join
- Progressive neurological dysfunction and major Stoke mRs > 3 without remission after 4 weeks from their last symptom.
- Advanced cancer patients with survivals < 3 years.
- Newly Myocardia infarction within previous 6 months.
- Stroke or TIA in connection with surgical procedure, heart surgery, neuro surgery or other major surgery.
- Stroke and TIA due to Carotid dissection.
- Stroke and TIA as urgently treated by EVT (endovascular trombendarterectomy)
- Unstable angina, or myocardial infarction within previous 6 months, or progressive neurological dysfunction or major surgery within the previous 30 days.
Trial locations and contacts
1 site in 1 country.
Saeid H Shahidi, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, 4000
Emilie N Eilersen, MD, +45 23285378, emilie.eilersen@gmail.com
About this study
Official title: Carotid Stenosis Management During COVID-19 Era - Best Medical Intervention Alone (CASCOM Pilot Study): A Prospective Observational Study
Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS in time. This study aims to measure the rate of ipsilateral stroke and other complications in individuals with symptomatic carotid stenosis, whom for any reason are managed using current best medical intervention alone. The investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials.
Read the detailed description
Background
Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. Patients also receive best medical treatment which is previously proven to reduce the risk of early recurrent neurological symptoms especially within the first 14 days of symptom onset (6). Further, there is no current evidence of procedural benefit compared to modern optimal medical intervention alone (lifestyle coaching and medication) for any individuals with carotid arterial disease (4,5). In some places the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS. Current guidelines recommend rapid revascularisation of symptomatic carotid stenosis. These guidelines are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today (4,5).
At a minimum these invasive interventions must be better justified.
Aim/Objectives
- To measure the rate of ipsilateral stroke, and other arterial disease complications in individuals with advanced (50-69% and 70-99%) symptomatic carotid stenosis who, for any reason, are managed using current best medical intervention alone. Reasons for a nonprocedural approach may include insufficient resources caused by the coronavirus pandemic, unproven procedural benefit, anticipated procedural futility and/or net harm, or patient refusal. Hence, the investigators will study patients for whom carotid procedures are not possible or considered unethical.
- To compare the CASCOM Pilot Study rate of ipsilateral stroke for symptomatic patients with that reported in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST).
Methods CASCOM Pilot Study is a prospective observational cohort study of current best medical intervention alone for stroke prevention. It consists of a prospective cohort study of current best medical intervention alone for stroke prevention. The investigators will separate patients into those who would and would not have been eligible for past randomised CEA trials. The investigators plan to study 310 symptomatic patients with 50-69% and 120 symptomatic patients with 70-99% ipsilateral stenosis using 'REDCap' (Research Electronic Data Capture) for case reporting.
Expected Findings and Significance In CASCOM Pilot Study the investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised controlled trials with very similar inclusion criteria.
If correct, CASCOM Pilot Study will provide new evidence that past randomised trials of CEA and CAS are outdated. Furthermore, this study will improve standards for stroke prevention and other arterial disease complications as well as to contribute to a necessary major international, multi-specialty observation study.
Primary Hypotheses:
Symptomatic Patients
- The 2-year rate of ipsilateral stroke from time of recruitment in symptomatic patients with ipsilateral 70-99% (NASCET) carotid stenosis receiving current best medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET(their rate was 26.0% using life-table analysis.
- The 2-year rate of ipsilateral stroke from time of recruitment in symptomatic patients with ipsilateral 50-69% (NASCET) carotid stenosis receiving current best medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET (their rate was 14.0% using life-table analysis.
Secondary Hypotheses:
Symptomatic Patients For symptomatic patients with 50-99% (NASCET) stenosis receiving current best medical intervention alone the 3-5-year ipsilateral carotid ischaemic stroke rate after randomization will be at least 50% lower compared to patients who had medical intervention alone in ECST and NASCET. 5-year ipsilateral ischaemic stroke rates for randomised trial patients were measured using pooled ECST and NASCET results, life-table analyses and according to different time intervals between the last ischaemic event and randomization.
Hypothesis 1:
Symptomatic Patients The 2-year rate of ipsilateral stroke in symptomatic patients with 70-99% (NASCET) carotid stenosis receiving current best available medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET. Require: 104/0.85 = 121 patients.
Hypothesis 2:
The 2-year rate of ipsilateral stroke in symptomatic patients with 50-69% (NASCET) carotid stenosis receiving current best available medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET. Require: 200/0.85 = 230 patients.
CASCOM Pilot study will also validate the CAR-Score < 15% for a 3-year risk for ipsilateral stroke in patients treated with best medical intervention.
We hope this pilot study would be a guide for implementation of an international multicenter CASCOM study.
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Embolus, Stroke
- Keywords
- carotid stenosis, stroke prevention, carotid arterial disease complication
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral stroke, myocardial infarction, death
Number of patients who gets recurrent ipsilateral stroke
Measured: Within 2 years of CASCOM-pilot study recruitment
Secondary outcomes (1)
Any territory stroke, ipsilateral transient ischemic attack, any territory ischemic attack, myocardial infarction, limb aputation, death from any cause and death from arterial disease
Number of patients who gets one of the above mentioned
Measured: Within 2 years of study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start11 Mar 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2026 (estimated)
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 Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie N Eilersen, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947046
- Sponsor's protocol ID
- P-2021-1
- Acronym
- CASCOM-Pilot
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, Rankin RN, Clagett GP, Hachinski VC, Sackett DL, Thorpe KE, Meldrum HE, Spence JD. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. 1998 Nov 12;339(20):1415-25. doi: 10.1056/NEJM199811123392002.
PubMed 9811916Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998 May 9;351(9113):1379-87.
PubMed 9593407MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet. 1991 May 25;337(8752):1235-43.
PubMed 1674060Abbott AL, Brunser AM, Giannoukas A, Harbaugh RE, Kleinig T, Lattanzi S, Poppert H, Rundek T, Shahidi S, Silvestrini M, Topakian R. Misconceptions regarding the adequacy of best medical intervention alone for asymptomatic carotid stenosis. J Vasc Surg. 2020 Jan;71(1):257-269. doi: 10.1016/j.jvs.2019.04.490. Epub 2019 Sep 26.
PubMed 31564585Abbott A. Critical Issues That Need to Be Addressed to Improve Outcomes for Patients With Carotid Stenosis. Angiology. 2016 May;67(5):420-6. doi: 10.1177/0003319716631266. Epub 2016 Feb 27.
PubMed 26922085Shahidi S, Owen-Falkenberg A, Gottschalksen B, Ellemann K. Risk of early recurrent stroke in symptomatic carotid stenosis after best medical therapy and before endarterectomy. Int J Stroke. 2016 Jan;11(1):41-51. doi: 10.1177/1747493015609777.
PubMed 26763019
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Stenosis Management During COVID-19 Era - Best Medical Intervention Alone (CASCOM Pilot Study): A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04947046
- Acronym / sponsor ID
- CASCOM-Pilot / P-2021-1
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Embolus, Stroke
- Keywords
- carotid stenosis, stroke prevention, carotid arterial disease complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Jul 2021 (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.
Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS in time. This study aims to measure the rate of ipsilateral stroke and other complications in individuals with symptomatic carotid stenosis, whom for any reason are managed using current best medical intervention alone. The investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials.
Detailed description
Background
Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. Patients also receive best medical treatment which is previously proven to reduce the risk of early recurrent neurological symptoms especially within the first 14 days of symptom onset (6). Further, there is no current evidence of procedural benefit compared to modern optimal medical intervention alone (lifestyle coaching and medication) for any individuals with carotid arterial disease (4,5). In some places the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS. Current guidelines recommend rapid revascularisation of symptomatic carotid stenosis. These guidelines are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today (4,5).
At a minimum these invasive interventions must be better justified.
Aim/Objectives
- To measure the rate of ipsilateral stroke, and other arterial disease complications in individuals with advanced (50-69% and 70-99%) symptomatic carotid stenosis who, for any reason, are managed using current best medical intervention alone. Reasons for a nonprocedural approach may include insufficient resources caused by the coronavirus pandemic, unproven procedural benefit, anticipated procedural futility and/or net harm, or patient refusal. Hence, the investigators will study patients for whom carotid procedures are not possible or considered unethical.
- To compare the CASCOM Pilot Study rate of ipsilateral stroke for symptomatic patients with that reported in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST).
Methods CASCOM Pilot Study is a prospective observational cohort study of current best medical intervention alone for stroke prevention. It consists of a prospective cohort study of current best medical intervention alone for stroke prevention. The investigators will separate patients into those who would and would not have been eligible for past randomised CEA trials. The investigators plan to study 310 symptomatic patients with 50-69% and 120 symptomatic patients with 70-99% ipsilateral stenosis using 'REDCap' (Research Electronic Data Capture) for case reporting.
Expected Findings and Significance In CASCOM Pilot Study the investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised controlled trials with very similar inclusion criteria.
If correct, CASCOM Pilot Study will provide new evidence that past randomised trials of CEA and CAS are outdated. Furthermore, this study will improve standards for stroke prevention and other arterial disease complications as well as to contribute to a necessary major international, multi-specialty observation study.
Primary Hypotheses:
Symptomatic Patients
- The 2-year rate of ipsilateral stroke from time of recruitment in symptomatic patients with ipsilateral 70-99% (NASCET) carotid stenosis receiving current best medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET(their rate was 26.0% using life-table analysis.
- The 2-year rate of ipsilateral stroke from time of recruitment in symptomatic patients with ipsilateral 50-69% (NASCET) carotid stenosis receiving current best medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET (their rate was 14.0% using life-table analysis.
Secondary Hypotheses:
Symptomatic Patients For symptomatic patients with 50-99% (NASCET) stenosis receiving current best medical intervention alone the 3-5-year ipsilateral carotid ischaemic stroke rate after randomization will be at least 50% lower compared to patients who had medical intervention alone in ECST and NASCET. 5-year ipsilateral ischaemic stroke rates for randomised trial patients were measured using pooled ECST and NASCET results, life-table analyses and according to different time intervals between the last ischaemic event and randomization.
Hypothesis 1:
Symptomatic Patients The 2-year rate of ipsilateral stroke in symptomatic patients with 70-99% (NASCET) carotid stenosis receiving current best available medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET. Require: 104/0.85 = 121 patients.
Hypothesis 2:
The 2-year rate of ipsilateral stroke in symptomatic patients with 50-69% (NASCET) carotid stenosis receiving current best available medical intervention alone will be at least 50% lower compared to patients given medical intervention alone in NASCET. Require: 200/0.85 = 230 patients.
CASCOM Pilot study will also validate the CAR-Score < 15% for a 3-year risk for ipsilateral stroke in patients treated with best medical intervention.
We hope this pilot study would be a guide for implementation of an international multicenter CASCOM study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced (50-99% or 60-99%, respectively) carotid stenosis in symptomatic patients who do not undergo CEA or CAS or similar procedures for any reason, including lack of resources caused by the coronavirus pandemic, situations of unproven procedural benefit, anticipated procedural futility or net harm or patient refusal. Hence, the investigators will study patients for whom carotid procedures are not possible or considered unethical.
Key inclusion criteria (15 listed)
- Patients who's life expectancy is > 3 years despite age > 80 years.
- Patients who have not been timely offered CEA under COVID-19 (eg women / men with 50-69%), which can only be operated on after 4 weeks after their last symptom.
- Patients with modified ranking scale (mRs) > 3, which during rehabilitation improve and move to mRs < 3.
- High risk cardio pulmonary patients (ejection fraction < 20% - severe chronic obstructive pulmonary disease) that is not estimated to withstand surgery or has a technically demanding neck anatomy with a life expectancy > 3 years.
- Patients who score below 15% on Carotid Artery Risk score (CAR-score) (5-year stroke risk is < 15% with only best medical treatment) for ipsilateral stroke.
Key exclusion criteria (7 listed)
- Progressive neurological dysfunction and major Stoke mRs > 3 without remission after 4 weeks from their last symptom.
- Advanced cancer patients with survivals < 3 years.
- Newly Myocardia infarction within previous 6 months.
- Stroke or TIA in connection with surgical procedure, heart surgery, neuro surgery or other major surgery.
- Stroke and TIA due to Carotid dissection.
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
Ipsilateral stroke, myocardial infarction, death
Time frame: Within 2 years of CASCOM-pilot study recruitment
Number of patients who gets recurrent ipsilateral stroke
1 secondary outcome
Any territory stroke, ipsilateral transient ischemic attack, any territory ischemic attack, myocardial infarction, limb aputation, death from any cause and death from arterial disease
Time frame: Within 2 years of study entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Background: PubMed 9811916Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, Rankin RN, Clagett GP, Hachinski VC, Sackett DL, Thorpe KE, Meldrum HE, Spence JD. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. 1998 Nov 12;339(20):1415-25. doi: 10.1056/NEJM199811123392002.
- Background: PubMed 9593407Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998 May 9;351(9113):1379-87.
- Background: PubMed 1674060MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet. 1991 May 25;337(8752):1235-43.
- Background: PubMed 31564585Abbott AL, Brunser AM, Giannoukas A, Harbaugh RE, Kleinig T, Lattanzi S, Poppert H, Rundek T, Shahidi S, Silvestrini M, Topakian R. Misconceptions regarding the adequacy of best medical intervention alone for asymptomatic carotid stenosis. J Vasc Surg. 2020 Jan;71(1):257-269. doi: 10.1016/j.jvs.2019.04.490. Epub 2019 Sep 26.
- Background: PubMed 26922085Abbott A. Critical Issues That Need to Be Addressed to Improve Outcomes for Patients With Carotid Stenosis. Angiology. 2016 May;67(5):420-6. doi: 10.1177/0003319716631266. Epub 2016 Feb 27.
- Background: PubMed 26763019Shahidi S, Owen-Falkenberg A, Gottschalksen B, Ellemann K. Risk of early recurrent stroke in symptomatic carotid stenosis after best medical therapy and before endarterectomy. Int J Stroke. 2016 Jan;11(1):41-51. doi: 10.1177/1747493015609777.
- Individual participant dataSharing planned: No
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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.
Saeid H Shahidi, MD contact
Emilie N Eilersen, MD principal investigator
Zealand University Hospital
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 Carotid Stenosis and Carotid Artery Diseases, run by Zealand University Hospital at 1 site in Denmark.
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 15 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Dec 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie N Eilersen, MD (+4523285378, emilie.eilersen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral stroke, myocardial infarction, death (time frame: Within 2 years of CASCOM-pilot study recruitment). 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 NCT04947046, 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 1 Dec 2021.