Acute Myocardial InfarctionNCT00839267
Clopidogrel Efficacy and Acute Coronary Syndromes
An observational study of Acute Myocardial Infarction, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2006to Dec 2008
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of 40 consecutive patients is planned, all of them with acute myocardial infarction with ST-segment elevation.
Who may be able to join
- acute STEMI
- mechanical ventilation
- the need for catecholamine support.
- acute myocardial infarction
Who cannot join
- previous treatment with clopidogrel
- clopidogrel administration during transport by ambulance
- known intolerance to clopidogrel
- history of thrombocytopenia (<150,000 platelets/ml)
- pre-existing liver disease
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
About this study
Official title: The Comparison of Clopidogrel Efficacy in Patients With Acute Myocardial Infarction and Severe Hemodynamic Instability to Patients With Hemodynamically Uncomplicated Myocardial Infarction
The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.
Read the detailed description
Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial infarction and severe hemodynamic instability. Therefore we would like to compare the effect of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI patients.
- Conditions
- Acute Myocardial Infarction
- Keywords
- platelet, VASP, clopidogrel, cardiogenic shock, myocardial infarction, percutaneous coronary intervention
- Medical subject headings
- Shock, Cardiogenic, Myocardial Infarction
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 |
|---|---|---|
| Unstable | Patient with acute myocardial infarction plus severe hemodynamical instability. It means, on mechanical ventilation and catecholamine support | |
| Stable | Patients with myocardial infarction hemodynamically completely (Killip I)stable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower efficacy of clopidogrel determined by VASP measurement
Measured: 6 months
Secondary outcomes (1)
Higher frequency of stent thrombosis in the unstable group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJun 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Investigators
- Pavel Osmancik, MD, PhD, Principal investigator, Charles University Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839267
- Sponsor's protocol ID
- CLO-OSM-02
- Status last verified
- Feb 2009
- First submitted
- 6 Feb 2009
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Clopidogrel Efficacy in Patients With Acute Myocardial Infarction and Severe Hemodynamic Instability to Patients With Hemodynamically Uncomplicated Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00839267
- Acronym / sponsor ID
- CLO-OSM-02
- Conditions
- Acute Myocardial Infarction
- Keywords
- platelet, VASP, clopidogrel, cardiogenic shock, myocardial infarction, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Feb 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 compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.
Detailed description
Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial infarction and severe hemodynamic instability. Therefore we would like to compare the effect of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable | – | –Patient with acute myocardial infarction plus severe hemodynamical instability. It means, on mechanical ventilation and catecholamine support |
| Stable | – | –Patients with myocardial infarction hemodynamically completely (Killip I)stable. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of 40 consecutive patients is planned, all of them with acute myocardial infarction with ST-segment elevation.
Key inclusion criteria (4 listed)
- acute STEMI
- mechanical ventilation
- the need for catecholamine support.
- acute myocardial infarction
Key exclusion criteria (5 listed)
- previous treatment with clopidogrel
- clopidogrel administration during transport by ambulance
- known intolerance to clopidogrel
- history of thrombocytopenia (<150,000 platelets/ml)
- pre-existing liver disease
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
Lower efficacy of clopidogrel determined by VASP measurement
Time frame: 6 months
1 secondary outcome
Higher frequency of stent thrombosis in the unstable group
Time frame: 6 months
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 10 Feb 2009.
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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.
Pavel Osmancik, MD, PhD principal investigator
Charles University Prague
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 Acute Myocardial Infarction, run by Charles University, Czech Republic at 1 site in Czechia.
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 5 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 10 Feb 2009. 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 Czechia. 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?
Lower efficacy of clopidogrel determined by VASP measurement (time frame: 6 months). 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 10 Feb 2009.