Coronary Artery DiseaseNCT00302913
Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition
A study testing Adjustment of clopidogrel dose in people with Coronary Artery Disease and Drug Resistance, run by University Heart Center Freiburg - Bad Krozingen at 1 site in Germany.
Trial summary
This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Drug Resistance
- What is being tested?
- Adjustment of clopidogrel dose
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to Jun 2006
- 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
- Patients undergoing elective coronary stenting
- Pretreatment with a bolus dose of 600mg of clopidogrel at least 2 hours prior to coronary stent implantation
- Pretreatment with aspirin ≥ 100 mg per day for at least 7 days
- Age > 18 years
- Written consent
Who cannot join
- Troponin T on admission > 0.03 ng/mL
- Myocardial infarction or fibrinolytic therapy within the previous 14 days
- Cardiogenic shock
- Contraindication for aspirin or clopidogrel
- Oral anticoagulation
- Pretreatment with heparin or a thienopyridine within the previous 14 days
Show all 11Show fewer
- Use of a GP IIb/IIIa-receptor antagonist during PCI
- Platelet count < 100.000/µl
- Severe disorders of the coagulation system
- Severe impairment of liver or kidney function
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting
This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation.
Read the detailed description
Background: The EXCELSIOR trial demonstrated a 7-fold increased risk for death, myocardial infarction and target vessel reintervention within 30 days in patients with platelet inhibition below median of study cohort after a bolus dose of 600 mg of clopidogrel. The median of platelet inhibition in this cohort was 14 % optical aggregation after stimulation with 5 µM ADP.
Aim: To evaluate the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation
Methods: This prospective, single-center study will evaluate antiplatelet effects in 120 patients receiving a bolus dose of 600 mg of clopidogrel before undergoing elective coronary stent implantation. Platelet inhibition will be evaluated 24 hours, 14 and 28 days after coronary intervention using optical aggregometry (5 µM ADP) and determination of surface protein expression by flow cytometry (P-Selectin, gp55, activated GP IIb/IIIa). If 24 hours after coronary stent implantation optical aggregation is >14 %, patients will receive an additional bolus dose of 300 mg of clopidogrel, followed by a daily dose of 150 mg for at least 28 days. If optical aggregation at this point of time is ≤14 % patients will receive a daily dose of 75 mg of clopidogrel. No further dose adjustments during follow up will be performed.
Hypothesis: Adjustment of clopidogrel dose in patients with insufficient platelet inhibition determined by optical aggregometry will provide a comparable antiplatelet effect as in patients with sufficient platelet inhibition after coronary stent implantation.
- Conditions
- Coronary Artery Disease, Drug Resistance
- Being tested
- Adjustment of clopidogrel dose
- Keywords
- Clopidogrel, Coronary Artery Disease, Dose-Response Relationship, Drug, Drug Resistance, PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustment of clopidogrel doseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiplatelet effect after fourteen and twenty-eight days determined by optical aggregometry after stimulation with ADP
Secondary outcomes (4)
Antiplatelet effect after fourteen and twenty-eight days determined by flow cytometric evaluation of surface protein expression after stimulation with ADP
Major cardiac events within thirty days (death, myocardial infarction, target vessel reintervention)
Bleeding and vascular access site complications within thirty days
Drug-drug interaction of clopidogrel with concomitant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startDec 2005
- Study completionJun 2006
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University Heart Center Freiburg - Bad Krozingen
- Sponsor type
- University, hospital or other
- Investigators
- Franz-Josef Neumann, MD, Study director, Heart Center Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302913
- Sponsor's protocol ID
- HZ-BK-2005-2
- Status last verified
- Feb 2006
- First submitted
- 14 Mar 2006
- Last updated
- 4 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting
- ClinicalTrials.gov ID
- NCT00302913
- Acronym / sponsor ID
- HZ-BK-2005-2
- Conditions
- Coronary Artery Disease, Drug Resistance
- Keywords
- Clopidogrel, Coronary Artery Disease, Dose-Response Relationship, Drug, Drug Resistance, PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- University Heart Center Freiburg - Bad KrozingenUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Jun 2006
- First posted
- 15 Mar 2006 (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.
This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation.
Detailed description
Background: The EXCELSIOR trial demonstrated a 7-fold increased risk for death, myocardial infarction and target vessel reintervention within 30 days in patients with platelet inhibition below median of study cohort after a bolus dose of 600 mg of clopidogrel. The median of platelet inhibition in this cohort was 14 % optical aggregation after stimulation with 5 µM ADP.
Aim: To evaluate the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation
Methods: This prospective, single-center study will evaluate antiplatelet effects in 120 patients receiving a bolus dose of 600 mg of clopidogrel before undergoing elective coronary stent implantation. Platelet inhibition will be evaluated 24 hours, 14 and 28 days after coronary intervention using optical aggregometry (5 µM ADP) and determination of surface protein expression by flow cytometry (P-Selectin, gp55, activated GP IIb/IIIa). If 24 hours after coronary stent implantation optical aggregation is >14 %, patients will receive an additional bolus dose of 300 mg of clopidogrel, followed by a daily dose of 150 mg for at least 28 days. If optical aggregation at this point of time is ≤14 % patients will receive a daily dose of 75 mg of clopidogrel. No further dose adjustments during follow up will be performed.
Hypothesis: Adjustment of clopidogrel dose in patients with insufficient platelet inhibition determined by optical aggregometry will provide a comparable antiplatelet effect as in patients with sufficient platelet inhibition after coronary stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective coronary stenting
- Pretreatment with a bolus dose of 600mg of clopidogrel at least 2 hours prior to coronary stent implantation
- Pretreatment with aspirin ≥ 100 mg per day for at least 7 days
- Age > 18 years
- Written consent
Key exclusion criteria (11 listed)
- Troponin T on admission > 0.03 ng/mL
- Myocardial infarction or fibrinolytic therapy within the previous 14 days
- Cardiogenic shock
- Contraindication for aspirin or clopidogrel
- Oral anticoagulation
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 |
|---|---|---|
| Adjustment of clopidogrel dose | Drug | – |
Primary outcome
Antiplatelet effect after fourteen and twenty-eight days determined by optical aggregometry after stimulation with ADP
4 secondary outcomes
Antiplatelet effect after fourteen and twenty-eight days determined by flow cytometric evaluation of surface protein expression after stimulation with ADP
Major cardiac events within thirty days (death, myocardial infarction, target vessel reintervention)
Bleeding and vascular access site complications within thirty days
Drug-drug interaction of clopidogrel with concomitant treatment
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 4 Jul 2006.
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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.
Franz-Josef Neumann, MD study director
Heart Center Bad Krozingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment of clopidogrel dose in people with Coronary Artery Disease and Drug Resistance, run by University Heart Center Freiburg - Bad Krozingen 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 5 inclusion and 11 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 4 Jul 2006. 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?
Antiplatelet effect after fourteen and twenty-eight days determined by optical aggregometry after stimulation with ADP. 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 4 Jul 2006.