Coronary Artery DiseaseNCT00742430
Resistance on Antithrombotic Drugs in Ischemic Heart Disease
An observational study of Coronary Artery Disease, run by University of Zagreb at 1 site in Croatia.
Trial summary
The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2009to Aug 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with coronary artery disease
Who may be able to join
- Elective PCI
- > 7 days on aspirin 100mg therapy before the intervention
- > 7 days on clopidogrel 75mg therapy before the intervention
Who cannot join
- Loading dose of clopidogrel
- < 7 days on aspirin therapy before the intervention
- Myocardial infarction less than 30 days before the intervention
- Cerebrovascular incident less that three months before the intervention
- Haemorrhagic diathesis
- Trc < 100
- Htc < 30%
- Creatinine > 140
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro
Zagreb, 10000
About this study
Official title: Assessment of Aspirin and Clopidogrel Resistance in Ischemic Heart Disease Using Multiplate Function Analyser and it's Correlation With Major Adverse Cardiac Events
The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD).
Read the detailed description
Our plan is to enroll 180 patients with diagnosed CAD who electively undergo percutaneous coronary intervention (PCI). Blood samples will be taken just before the procedure and one day after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance incidence using Multiplate platelet function analyzer we will also try to find resistance correlation with the incidence of major adverse cardiac events in a one year follow up.
- Conditions
- Coronary Artery Disease
- Being tested
- PCI
- Keywords
- aspirin resistance, coronary artery disease, clopidogrel resistance, major adverse cardiac events, multiplate platelet function analyser, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Also called stenting, PTCA, balloon dilatation
percutaneous coronary intervention in stable coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Resistant | patients who are resistant to standard antithrombotic drugs Receives: Procedure: PCI | |
| Nonresistant | patients who are not resistant to standard dual antithrombotic drugs Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse coronary event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startFeb 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davor Milicic, University of Zagreb
- Investigators
- Davor Milicic, prof.dr.sc., Principal investigator, Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, CroatiaBosko Skoric, dr., Study chair, Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742430
- Sponsor's protocol ID
- 108-1081875-1993
- Status last verified
- Feb 2012
- First submitted
- 26 Aug 2008
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Aspirin and Clopidogrel Resistance in Ischemic Heart Disease Using Multiplate Function Analyser and it's Correlation With Major Adverse Cardiac Events
- ClinicalTrials.gov ID
- NCT00742430
- Acronym / sponsor ID
- 108-1081875-1993
- Conditions
- Coronary Artery Disease
- Keywords
- aspirin resistance, coronary artery disease, clopidogrel resistance, major adverse cardiac events, multiplate platelet function analyser, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Aug 2008 (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 determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD).
Detailed description
Our plan is to enroll 180 patients with diagnosed CAD who electively undergo percutaneous coronary intervention (PCI). Blood samples will be taken just before the procedure and one day after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance incidence using Multiplate platelet function analyzer we will also try to find resistance correlation with the incidence of major adverse cardiac events in a one year follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant | – | Procedure: PCIpatients who are resistant to standard antithrombotic drugs |
| Nonresistant | – | Procedure: PCIpatients who are not resistant to standard dual antithrombotic drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with coronary artery disease
Key inclusion criteria (3 listed)
- Elective PCI
- > 7 days on aspirin 100mg therapy before the intervention
- > 7 days on clopidogrel 75mg therapy before the intervention
Key exclusion criteria (8 listed)
- Loading dose of clopidogrel
- < 7 days on aspirin therapy before the intervention
- Myocardial infarction less than 30 days before the intervention
- Cerebrovascular incident less that three months before the intervention
- Haemorrhagic diathesis
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 |
|---|---|---|
| PCIAlso: stenting, PTCA, balloon dilatationpercutaneous coronary intervention in stable coronary artery disease | Procedure or surgery | Nonresistant, Resistant |
Primary outcome
Major adverse coronary event
Time frame: 12 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 14 Feb 2012.
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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.
Davor Milicic, prof.dr.sc. principal investigator
Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia
Bosko Skoric, dr. study chair
Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia
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 Coronary Artery Disease, run by University of Zagreb at 1 site in Croatia.
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 3 inclusion and 8 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 14 Feb 2012. 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 Croatia. 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 adverse coronary event (time frame: 12 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 14 Feb 2012.