Coronary Artery DiseaseNCT00839345
Clopidogrel Resistance and the Possibility of Its Affection
A study testing clopidogrel in people with Coronary Artery Disease, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- clopidogrel
- How many people
- Not given
- Where
- 1 siteCzechia
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- written informed consent
- coronary artery disease verified by coronary angiography
- percutaneous coronary intervention with stent implantation
- standard indication for dual antiplatelet therapy
Who cannot join
- scheduled surgical revascularization by aortocoronary bypass
- insufficient cooperation of the patient
- coagulopathy in history with a higher risk of bleeding
- life expectancy shorter than 1 year
- severe anemia with hemoglobin level< 10,0 g/dl
- platelet count < 100,000)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Cardiocenter, Dept. Of Cardiology, Charles University Hospital
Prague, 10034
About this study
Official title: Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection
The purpose of the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine.
Read the detailed description
Patients after percutaneous coronary intervention (PCI) with stent implantation have to be treated by dual antiplatelet therapy, which standard part represents clopidogrel. The response to clopidogrel in population exhibits wide interindividual variability. According to some recent works, patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness. The treatment of clopidogrel resistance is still unknown. Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination. We will test the hypothesis, whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine (ADP antagonist with different biotransformation in the liver). Therefore, 500 pts. will be tested to clopidogrel resistance. We expect 5-10% of resistent pts. This pts. will be treated by higher dose (150mg or 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day will be insufficient, clopidogrel will be replaced by ticlopidine with repeated test. We expect, that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder. Nevertheless, the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment
- Conditions
- Coronary Artery Disease
- Being tested
- clopidogrel
- Keywords
- platelet, clopidogrel, VerifyNow, ticlopidine, thrombosis
- Medical subject headings
- Coronary Artery Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Plavix
The intervention will involve the change of dosage or change of drug. The traditional maintenance dose of clopidogrel is 75 mg per day. We will test in non-responders to this classical dose higher doses up to 225mg per day. In patients,who will not respond to this 3times higher dose,clopidogrel will be replaced by ticlopidine.
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)
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.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Osmancik, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839345
- Sponsor's protocol ID
- CLO-OSM-01
- Status last verified
- Jan 2019
- First submitted
- 6 Feb 2009
- Last updated
- 1 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection
- ClinicalTrials.gov ID
- NCT00839345
- Acronym / sponsor ID
- CLO-OSM-01
- Conditions
- Coronary Artery Disease
- Keywords
- platelet, clopidogrel, VerifyNow, ticlopidine, thrombosis
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- 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 the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine.
Detailed description
Patients after percutaneous coronary intervention (PCI) with stent implantation have to be treated by dual antiplatelet therapy, which standard part represents clopidogrel. The response to clopidogrel in population exhibits wide interindividual variability. According to some recent works, patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness. The treatment of clopidogrel resistance is still unknown. Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination. We will test the hypothesis, whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine (ADP antagonist with different biotransformation in the liver). Therefore, 500 pts. will be tested to clopidogrel resistance. We expect 5-10% of resistent pts. This pts. will be treated by higher dose (150mg or 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day will be insufficient, clopidogrel will be replaced by ticlopidine with repeated test. We expect, that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder. Nevertheless, the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment
Study design
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent
- coronary artery disease verified by coronary angiography
- percutaneous coronary intervention with stent implantation
- standard indication for dual antiplatelet therapy
Key exclusion criteria (6 listed)
- scheduled surgical revascularization by aortocoronary bypass
- insufficient cooperation of the patient
- coagulopathy in history with a higher risk of bleeding
- life expectancy shorter than 1 year
- severe anemia with hemoglobin level< 10,0 g/dl
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 |
|---|---|---|
| clopidogrelAlso: PlavixThe intervention will involve the change of dosage or change of drug. The traditional maintenance dose of clopidogrel is 75 mg per day. We will test in non-responders to this classical dose higher doses up to 225mg per day. In patients,who will not respond to this 3times higher dose,clopidogrel will be replaced by ticlopidine. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clopidogrel in people with Coronary Artery Disease, 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 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: status not confirmed, as of the sponsor's last update on 1 Feb 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 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?
Results are not available in the source record.
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.
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 1 Feb 2019.