Mini-StrokeINSPiRE-TMSNCT01586702
Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients
A study testing Patient centered structured support program in people with Mini-Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mini-Stroke
- What is being tested?
- Patient centered structured support program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,082 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to May 2019
- Phase
- Interventional
- 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
- Acute cerebrovascular event (either TIA or minor Stroke within 14 days before study inclusion) according to the following definitions:
- TIA (clinical restitution within 24 hours and ABCD2-Score ≥3) or visible DWI-lesion in MRI
- Minor stroke (mRankin ≤2 at time of inclusion)
- Patients with at least one of the following treatable risk factors:
- Arterial Hypertension
- Diabetes mellitus
Show all 10Show fewer
- Atrial Fibrillation
- Smoking
- Written informed consent prior to study inclusion
- Realistic perspective in keeping the outpatient appointments
Who cannot join
- Distance from home to study center not in suitable range for keeping the outpatient appointments
- cognitive impairment jeopardizing adherence to the support program
- Modified Rankin Score >2 at time of study inclusion
- Malignant disease with life expectancy of less than 3 years
- relevant alcohol or other substance abuse (except for nicotine)
- Stroke or TIA etiology without options for evidence based secondary prevention (e.g. dissection or vasculitis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Neurology, Charité Universitätsmedizin Berlin
Berlin, 12200
About this study
Official title: Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car
Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.
Read the detailed description
Although effective methods of secondary prevention after stroke or TIA are available, adherence to recommended evidence-based treatments is often poor. Programs for supported secondary prevention after cerebrovascular events with improved health education are promising but have not been evaluated regarding recurrent event reduction so far.
A prospective randomized trial has been started to assess the effectiveness of a patient centered structured support program intending a reduction of recurrent vascular events. Usual care consists of structured information given at discharge as well as regular outpatient care by general practitioners. The support program additionally employs a stepwise intensified support program with up to eight appointments over two years in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. They are also offered assistance in finding appropriate physical activities or smoking cessation programs.
Patients are randomized to regular care or regular care plus support program and will be followed-up until the total number of 317 primary endpoints has been reached. The composite primary endpoint consists of stroke, major coronary event and vascular death.
- Conditions
- Mini-Stroke
- Being tested
- Patient centered structured support program
- Keywords
- Stroke, TIA, secondary prevention, support program, multifactorial intervention
- Medical subject headings
- Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient centered structured support programBehavioural
Also called Intensified secondary prevention
Behavioural: Structured support program
Program with up to 8 outpatient appointments focusing on:
- Measurement of risk factors
- Assessment of medication intake
- Monitoring of antithrombotic therapy
- Joint agreement of an individual target plan
Target values for risk factors:
- Blood pressure < 140/85 mmHg (<130/80 in diabetics), normal circadian profile
- HbA1c <7.5%
- Nicotine abstinence
- LDL < 100mg/dl (< 70mg/dl in high risk patients)
- Physical activity ≥ 30min >2 x / week
Targets for pharmaceutical treatment:
- Platelet inhibitors for strokes / TIA of arterial etiology
- Combined platelet inhibition over 3 months in symptomatic intra- or extracranial stenosis
- Cumarins (INR 2-3) or new oral anticoagulants in AF patients
- Statin treatment in patients with LDL >100mg/dl
Intervention strategies:
- According to Motivational Interviewing
| Study group | Role | What they receive |
|---|---|---|
| Regular care | No intervention | Consisting of structured information given at hospital discharge regarding stroke etiology and recommended secondary prevention plus regular outpatient care by general practitioners or family doctors. |
| Support program | Active comparator | In addition to regular care: Up to 8 appointments in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. In case that a patients fails to meet target values, preventive measures will be modified directly or via recommendation to GPs / family doctors. Patients are also offered assistance in finding appropriate physical activities or smoking cessation programs. Receives: Behavioral: Patient centered structured support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death
Stroke: Acute (focal-) neurological syndrome, caused by brain infarction or intracerebral hemorrhage Major coronary event:Including instable Angina pectoris, STEMI and non-STEMI Vascular death: Caused by stroke (within 30 days of event), or major coronary event (within 7 days of event), or non-cerebral hemorrhage, or by peripheral arterial disease 30 days after vascular event or vascular intervention (intraarterial or surgical), or by pulmonary embolism or sudden death if death occurs within 24 hours in a patients with previously stable and healthy state if no non-vascular cause is documented
Measured: Up to 6 years from inclusion
Secondary outcomes (7)
Non vascular death
Measured: Participants will be followed-up for an average of approximately 3.5 years
Other vascular diseases leading to hospital admission (excl. primary outcome measure)
Consisting of TIA, Angina pectoris, PAD with vascular intervention
Measured: Participants will be followed-up for an average of approximately 3.5 years
All hospital admissions with vascular intervention (intraarterial or surgical)
Measured: Participants will be followed-up for an average of approximately 3.5 years
Bleedings
All bleedings leading to therapeutic intervention (categorized according to GUSTO definitions)
Measured: Participants will be followed-up for an average of approximately 3.5 years
Level of dependency
Assessment according to modified Rankin Score and level of care (German care insurance)
Measured: Up to 6 years from inclusion
All hospital admissions
Measured: Participants will be followed-up for an average of approximately 3.5 years
Days alive and at home
Measured: Participants will be followed-up for an average of approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mini-StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, University of Erlangen-Nürnberg Medical School, Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München, Technische Universität Berlin, Aarhus University Hospital, Klinikum Ludwigshafen, Vivantes Auguste-Viktoria-Klinikum, Vivantes Clinic Neukölln
- Responsible party
- Principal investigator, Heinrich J Audebert, Charite University, Berlin, Germany
- Investigators
- Heinrich J Audebert, MD, Principal investigator, Center for Stroke Research, Charité Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586702
- Sponsor's protocol ID
- EA2/084/11
- Acronym
- INSPiRE-TMS
- Status last verified
- Jul 2019
- First submitted
- 23 Apr 2012
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang Y, Temuulen U, Rios AS, Khalil A, Ahmadi M, Horn A, Endres M, Audebert HJ, Kufner A. Neuroanatomical correlates of stroke-related dizziness and vertigo: secondary analysis from the INSPiRE-TMS trial. J Neurol. 2026 Aug 12;273(9):524. doi: 10.1007/s00415-026-14033-3.
PubMed 42584697Stegemann A, Rios AS, Khalil A, Grittner U, Temuulen U, Ganeshan R, Braemswig TB, Horn A, Ihl T, Audebert HJ, Kufner A, Endres M. Neuroimaging Correlates of Post-Stroke Pain After Ischemic Stroke: Secondary Analysis of the INSPiRE-TMS Trial. Hum Brain Mapp. 2026 Jul;47(10):e70602. doi: 10.1002/hbm.70602.
PubMed 42420807Roesen P, Temuulen U, Rios AS, Ganeshan R, Braemswig TB, Khalil A, Villringer K, Ihl T, Ali HF, Gebert P, Grittner U, Ahmadi M, Puy L, Cordonnier C, Endres M, Audebert HJ, Kufner A. Baseline Cerebral Small Vessel Disease Predicting Long-Term Cognitive Decline in Transient Ischemic Attack Patients. Eur J Neurol. 2026 Apr;33(4):e70578. doi: 10.1111/ene.70578.
PubMed 41885058Stegemann A, Rios AS, Khalil A, Grittner U, Temuulen U, Ganeshan R, Braemswig TB, Horn A, Ihl T, Audebert HJ, Kufner A, Endres M. Neuroimaging Correlates of Post-Stroke Pain After Ischemic Stroke: Secondary Analysis of the INSPiRE-TMS Trial. medRxiv [Preprint]. 2025 Aug 11:2025.08.07.25333248. doi: 10.1101/2025.08.07.25333248.
PubMed 40832386Ihl T, Ahmadi M, Laumeier I, Steinicke M, Ferse C, Klyscz P, Endres M, Hastrup S, Poppert H, Palm F, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Audebert HJ. Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial. Stroke. 2022 Sep;53(9):2730-2738. doi: 10.1161/STROKEAHA.120.037503. Epub 2022 Jun 15.
PubMed 35703097Ahmadi M, Laumeier I, Ihl T, Steinicke M, Ferse C, Endres M, Grau A, Hastrup S, Poppert H, Palm F, Schoene M, Seifert CL, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Algra A, Amarenco P, Greving JP, Busse O, Kohler F, Marx P, Audebert HJ. A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial. Lancet Neurol. 2020 Jan;19(1):49-60. doi: 10.1016/S1474-4422(19)30369-2. Epub 2019 Nov 7.
PubMed 31708447Leistner S, Michelson G, Laumeier I, Ahmadi M, Smyth M, Nieweler G, Doehner W, Sobesky J, Fiebach JB, Marx P, Busse O, Kohler F, Poppert H, Wimmer ML, Knoll T, Von Weitzel-Mudersbach P, Audebert HJ. Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial. BMC Neurol. 2013 Jan 24;13:11. doi: 10.1186/1471-2377-13-11.
PubMed 23347503Leistner S, Benik S, Laumeier I, Ziegler A, Nieweler G, Nolte CH, Heuschmann PU, Audebert HJ. Secondary prevention after minor stroke and TIA - usual care and development of a support program. PLoS One. 2012;7(12):e49985. doi: 10.1371/journal.pone.0049985. Epub 2012 Dec 17.
PubMed 23284630
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car
- ClinicalTrials.gov ID
- NCT01586702
- Acronym / sponsor ID
- INSPiRE-TMS / EA2/084/11
- Conditions
- Mini-Stroke
- Keywords
- Stroke, TIA, secondary prevention, support program, multifactorial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,082 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Technical University of Munich, University of Erlangen-Nürnberg Medical School, Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München, Technische Universität Berlin, Aarhus University Hospital, Klinikum Ludwigshafen, Vivantes Auguste-Viktoria-Klinikum, Vivantes Clinic Neukölln
- Study start
- Sep 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 27 Apr 2012 (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.
Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.
Detailed description
Although effective methods of secondary prevention after stroke or TIA are available, adherence to recommended evidence-based treatments is often poor. Programs for supported secondary prevention after cerebrovascular events with improved health education are promising but have not been evaluated regarding recurrent event reduction so far.
A prospective randomized trial has been started to assess the effectiveness of a patient centered structured support program intending a reduction of recurrent vascular events. Usual care consists of structured information given at discharge as well as regular outpatient care by general practitioners. The support program additionally employs a stepwise intensified support program with up to eight appointments over two years in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. They are also offered assistance in finding appropriate physical activities or smoking cessation programs.
Patients are randomized to regular care or regular care plus support program and will be followed-up until the total number of 317 primary endpoints has been reached. The composite primary endpoint consists of stroke, major coronary event and vascular death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular care | No intervention | –Consisting of structured information given at hospital discharge regarding stroke etiology and recommended secondary prevention plus regular outpatient care by general practitioners or family doctors. |
| Support program | Active comparator | Behavioral: Patient centered structured support programIn addition to regular care: Up to 8 appointments in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. In case that a patients fails to meet target values, preventive measures will be modified directly or via recommendation to GPs / family doctors. Patients are also offered assistance in finding appropriate physical activities or smoking cessation programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acute cerebrovascular event (either TIA or minor Stroke within 14 days before study inclusion) according to the following definitions:
- TIA (clinical restitution within 24 hours and ABCD2-Score ≥3) or visible DWI-lesion in MRI
- Minor stroke (mRankin ≤2 at time of inclusion)
- Patients with at least one of the following treatable risk factors:
- Arterial Hypertension
Key exclusion criteria (6 listed)
- Distance from home to study center not in suitable range for keeping the outpatient appointments
- cognitive impairment jeopardizing adherence to the support program
- Modified Rankin Score >2 at time of study inclusion
- Malignant disease with life expectancy of less than 3 years
- relevant alcohol or other substance abuse (except for nicotine)
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 |
|---|---|---|
| Patient centered structured support programAlso: Intensified secondary preventionBehavioural: Structured support program Program with up to 8 outpatient appointments focusing on: * Measurement of risk factors * Assessment of medication intake * Monitoring of antithrombotic therapy * Joint agreement of an individual target plan Target values for risk factors: * Blood pressure < 140/85 mmHg (<130/80 in diabetics), normal circadian profile * HbA1c <7.5% * Nicotine abstinence * LDL < 100mg/dl (< 70mg/dl in high risk patients) * Physical activity ≥ 30min >2 x / week Targets for pharmaceutical treatment: * Platelet inhibitors for strokes / TIA of arterial etiology * Combined platelet inhibition over 3 months in symptomatic intra- or extracranial stenosis * Cumarins (INR 2-3) or new oral anticoagulants in AF patients * Statin treatment in patients with LDL >100mg/dl Intervention strategies: • According to Motivational Interviewing | Behavioural | Support program |
Primary outcome
Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death
Time frame: Up to 6 years from inclusion
Stroke: Acute (focal-) neurological syndrome, caused by brain infarction or intracerebral hemorrhage Major coronary event:Including instable Angina pectoris, STEMI and non-STEMI Vascular death: Caused by stroke (within 30 days of event), or major coronary event (within 7 days of event), or non-cerebral hemorrhage, or by peripheral arterial disease 30 days after vascular event or vascular intervention (intraarterial or surgical), or by pulmonary embolism or sudden death if death occurs within 24 hours in a patients with previously stable and healthy state if no non-vascular cause is documented
7 secondary outcomes
Non vascular death
Time frame: Participants will be followed-up for an average of approximately 3.5 years
Other vascular diseases leading to hospital admission (excl. primary outcome measure)
Time frame: Participants will be followed-up for an average of approximately 3.5 years
All hospital admissions with vascular intervention (intraarterial or surgical)
Time frame: Participants will be followed-up for an average of approximately 3.5 years
Bleedings
Time frame: Participants will be followed-up for an average of approximately 3.5 years
Level of dependency
Time frame: Up to 6 years from inclusion
All hospital admissions
Time frame: Participants will be followed-up for an average of approximately 3.5 years
Days alive and at home
Time frame: Participants will be followed-up for an average of approximately 3.5 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 23 Jul 2019.
- Derived from this study: PubMed 42584697Tang Y, Temuulen U, Rios AS, Khalil A, Ahmadi M, Horn A, Endres M, Audebert HJ, Kufner A. Neuroanatomical correlates of stroke-related dizziness and vertigo: secondary analysis from the INSPiRE-TMS trial. J Neurol. 2026 Aug 12;273(9):524. doi: 10.1007/s00415-026-14033-3.
- Derived from this study: PubMed 42420807Stegemann A, Rios AS, Khalil A, Grittner U, Temuulen U, Ganeshan R, Braemswig TB, Horn A, Ihl T, Audebert HJ, Kufner A, Endres M. Neuroimaging Correlates of Post-Stroke Pain After Ischemic Stroke: Secondary Analysis of the INSPiRE-TMS Trial. Hum Brain Mapp. 2026 Jul;47(10):e70602. doi: 10.1002/hbm.70602.
- Derived from this study: PubMed 41885058Roesen P, Temuulen U, Rios AS, Ganeshan R, Braemswig TB, Khalil A, Villringer K, Ihl T, Ali HF, Gebert P, Grittner U, Ahmadi M, Puy L, Cordonnier C, Endres M, Audebert HJ, Kufner A. Baseline Cerebral Small Vessel Disease Predicting Long-Term Cognitive Decline in Transient Ischemic Attack Patients. Eur J Neurol. 2026 Apr;33(4):e70578. doi: 10.1111/ene.70578.
- Derived from this study: PubMed 40832386Stegemann A, Rios AS, Khalil A, Grittner U, Temuulen U, Ganeshan R, Braemswig TB, Horn A, Ihl T, Audebert HJ, Kufner A, Endres M. Neuroimaging Correlates of Post-Stroke Pain After Ischemic Stroke: Secondary Analysis of the INSPiRE-TMS Trial. medRxiv [Preprint]. 2025 Aug 11:2025.08.07.25333248. doi: 10.1101/2025.08.07.25333248.
- Derived from this study: PubMed 35703097Ihl T, Ahmadi M, Laumeier I, Steinicke M, Ferse C, Klyscz P, Endres M, Hastrup S, Poppert H, Palm F, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Audebert HJ. Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial. Stroke. 2022 Sep;53(9):2730-2738. doi: 10.1161/STROKEAHA.120.037503. Epub 2022 Jun 15.
- Derived from this study: PubMed 31708447Ahmadi M, Laumeier I, Ihl T, Steinicke M, Ferse C, Endres M, Grau A, Hastrup S, Poppert H, Palm F, Schoene M, Seifert CL, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Algra A, Amarenco P, Greving JP, Busse O, Kohler F, Marx P, Audebert HJ. A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial. Lancet Neurol. 2020 Jan;19(1):49-60. doi: 10.1016/S1474-4422(19)30369-2. Epub 2019 Nov 7.
- Derived from this study: PubMed 23347503Leistner S, Michelson G, Laumeier I, Ahmadi M, Smyth M, Nieweler G, Doehner W, Sobesky J, Fiebach JB, Marx P, Busse O, Kohler F, Poppert H, Wimmer ML, Knoll T, Von Weitzel-Mudersbach P, Audebert HJ. Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial. BMC Neurol. 2013 Jan 24;13:11. doi: 10.1186/1471-2377-13-11.
- Derived from this study: PubMed 23284630Leistner S, Benik S, Laumeier I, Ziegler A, Nieweler G, Nolte CH, Heuschmann PU, Audebert HJ. Secondary prevention after minor stroke and TIA - usual care and development of a support program. PLoS One. 2012;7(12):e49985. doi: 10.1371/journal.pone.0049985. Epub 2012 Dec 17.
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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.
Heinrich J Audebert, MD principal investigator
Center for Stroke Research, Charité Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient centered structured support program in people with Mini-Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
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 10 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 23 Jul 2019. 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 Germany. 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?
Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (time frame: Up to 6 years from inclusion). 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 NCT01586702, which also lists 8 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 23 Jul 2019.