Test the Efficacy of Antiplatelet Regimes in Acute StrokeNCT01273935
Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke
An observational study of Test the Efficacy of Antiplatelet Regimes in Acute Stroke, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Test the Efficacy of Antiplatelet Regimes in Acute Stroke
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2010
- 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: Patients admitted to the stroke unit
Who may be able to join
- suspected acute cerebrovascular ischemic events and patients who were admitted to the stroke unit where antiplatelet therapy was initiated
Who cannot join
- severe liver disorders, current gastrointestinal disorders, congestive heart failure, life-threatening malignancies and a personal or family history of bleeding disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, St. Josef - Hospital, Ruhr-University
Bochum, North Rhine-Westphalia, D-44791
About this study
The aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).
Read the detailed description
Antiplatelet agents are important therapeutic options in treating patients with acute ischemic strokes to prevent recurrent ischemic events or death. The aim of this study was to evaluate the low-response prevalence of early antiplatelet therapy and the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).
- Keywords
- Aspirin, Acute Cerebrovascular Ischemia, Platelet Function
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 |
|---|---|---|
| Responder | Responder versus Non-Responder as a result of platelet function test | |
| Non-Responder | According to the result of platelet function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of platelet function test
Aggregometry result of antiplatelet therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJan 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test the Efficacy of Antiplatelet Regimes in Acute 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Investigators
- Saskia H Meves, MD, Principal investigator, Department of Neurology, St. Josef - Hospital, Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273935
- Sponsor's protocol ID
- MevesASS01
- Status last verified
- Jan 2010
- First submitted
- 10 Jan 2011
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01273935
- Acronym / sponsor ID
- MevesASS01
- Keywords
- Aspirin, Acute Cerebrovascular Ischemia, Platelet Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jan 2010
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jan 2011 (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 aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).
Detailed description
Antiplatelet agents are important therapeutic options in treating patients with acute ischemic strokes to prevent recurrent ischemic events or death. The aim of this study was to evaluate the low-response prevalence of early antiplatelet therapy and the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responder | – | –Responder versus Non-Responder as a result of platelet function test |
| Non-Responder | – | –According to the result of platelet function test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the stroke unit
Key inclusion criteria (1 listed)
- suspected acute cerebrovascular ischemic events and patients who were admitted to the stroke unit where antiplatelet therapy was initiated
Key exclusion criteria (1 listed)
- severe liver disorders, current gastrointestinal disorders, congestive heart failure, life-threatening malignancies and a personal or family history of bleeding disorders
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
Result of platelet function test
Aggregometry result of antiplatelet therapy
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 11 Jan 2011.
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.
Saskia H Meves, MD principal investigator
Department of Neurology, St. Josef - Hospital, Bochum, Germany
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 Test the Efficacy of Antiplatelet Regimes in Acute Stroke, run by Ruhr University of Bochum 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 1 inclusion and 1 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 11 Jan 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 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?
Result of platelet function test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2011.