Coronary Artery DiseaseEXCELSIORNCT00457236
Effect of Clopidogrel Loading and Risk of PCI
An observational study of 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 impact of the variability in platelet response after loading with clopidogrel on the peri-interventional risk of patients undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Drug Resistance
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Dec 2007
- 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
Who may be able to join
- Patients undergoing elective coronary stenting
- Pretreatment with a bolus dose of 600mg of clopidogrel 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: Impact of the Degree of Peri-Interventional Platelet Inhibition After Loading With Clopidogrel on Early Clinical Outcome of Elective Coronary Stent Placement
This study is a prospective, single-center evaluation of the impact of the variability in platelet response after loading with clopidogrel on the peri-interventional risk of patients undergoing PCI.
Read the detailed description
Background: Platelet responses after loading with clopidogrel are highly variable. The impact of this variability on the peri-interventional risk of patients undergoing PCI has not been investigated prospectively.
Objectives: Our prospective study test the hypothesis that the 30-day clinical outcome of elective percutaneous catheter intervention (PCI) differs between strata defined by quartiles of platelet aggregation after loading with 600mg of clopidogrel. Further on we will investigate impact of the variability in platelet response on long-term outcome after PCI.
Methods: Our study will include consecutive patients undergoing elective coronary stent placement. Before PCI, patients receive a loading dose of 600mg of clopidogrel followed by 75mg daily. Primary end point is the 30-day composite of death, myocardial infarction and target lesion revascularization (MACE). Platelet aggregation was assessed immediately before PCI by optical aggregometry (5µmol/L ADP).
Sample size calculation was based on ISAR-REACT which comprised a cohort with similar selection criteria and treatment strategy. Thus, we assume an incidence of the primary end point of 4.2%. We design our study to test the hypothesis that the incidence of the primary end point differed by quartiles of ADP-induced platelet aggregation. We intend to have a power of 0.80 to detect an effect size of 0.015 (for example 3-fold risk in 4th quartile) with a 2-sided P-value less than 0.05. With these assumptions we obtain a sample size of at least 748 and aime for a cohort of 800.
- Conditions
- Coronary Artery Disease, Drug Resistance
- Keywords
- Clopidogrel, Coronary Artery Disease, Dose-Response Relationship, Drug, Drug Resistance, PCI
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMar 2003
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 800 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
- NCT00457236
- Sponsor's protocol ID
- HZ-BK-2003-1
- Acronym
- EXCELSIOR
- Status last verified
- Apr 2007
- First submitted
- 4 Apr 2007
- Last updated
- 6 Apr 2007
- Results posted
- No
Publications
Hochholzer W, Trenk D, Bestehorn HP, Fischer B, Valina CM, Ferenc M, Gick M, Caputo A, Buttner HJ, Neumann FJ. Impact of the degree of peri-interventional platelet inhibition after loading with clopidogrel on early clinical outcome of elective coronary stent placement. J Am Coll Cardiol. 2006 Nov 7;48(9):1742-50. doi: 10.1016/j.jacc.2006.06.065. Epub 2006 Oct 17.
PubMed 17084243Kille A, Kaier K, Nuhrenberg T, Franke K, Valina CM, Yang X, Leibundgut G, Neumann FJ, Westermann D, Hochholzer W, Tsimikas S. Oxidized phospholipids on plasminogen are associated with reduced platelet surface marker expression and intrinsic reactivity. J Thromb Thrombolysis. 2026 Feb;59(2):261-271. doi: 10.1007/s11239-025-03210-2. Epub 2026 Jan 12.
PubMed 41525016Tsimikas S, Kille A, Kaier K, Nuhrenberg T, Franke K, Valina CM, Yang X, Leibundgut G, Neumann FJ, Westermann D, Hochholzer W. Oxidized Phospholipids on ApoB-100, Platelet Activation and Reactivity, and Long-Term Cardiovascular Outcomes. Arterioscler Thromb Vasc Biol. 2025 Oct;45(10):1935-1944. doi: 10.1161/ATVBAHA.125.322347. Epub 2025 Aug 14.
PubMed 40808656Valina CM, Merz S, Loffelhardt N, Amann M, Ferenc M, Stratz C, Neumann FJ, Hochholzer W. Risk of discontinuation of clopidogrel after 1 month following bare-metal stents: a propensity-score adjusted comparison with continued administration of clopidogrel after drug-eluting stents. J Thromb Thrombolysis. 2018 Apr;45(3):432-439. doi: 10.1007/s11239-018-1613-6.
PubMed 29349545Hochholzer W, Valina CM, Stratz C, Amann M, Schlittenhardt D, Buttner HJ, Trenk D, Neumann FJ. High-sensitivity cardiac troponin for risk prediction in patients with and without coronary heart disease. Int J Cardiol. 2014 Sep 20;176(2):444-9. doi: 10.1016/j.ijcard.2014.07.094. Epub 2014 Aug 4.
PubMed 25127973Trenk D, Hochholzer W, Fromm MF, Zolk O, Valina CM, Stratz C, Neumann FJ. Paraoxonase-1 Q192R polymorphism and antiplatelet effects of clopidogrel in patients undergoing elective coronary stent placement. Circ Cardiovasc Genet. 2011 Aug 1;4(4):429-36. doi: 10.1161/CIRCGENETICS.111.960112. Epub 2011 Jun 17.
PubMed 21685174Hochholzer W, Trenk D, Fromm MF, Valina CM, Stratz C, Bestehorn HP, Buttner HJ, Neumann FJ. Impact of cytochrome P450 2C19 loss-of-function polymorphism and of major demographic characteristics on residual platelet function after loading and maintenance treatment with clopidogrel in patients undergoing elective coronary stent placement. J Am Coll Cardiol. 2010 Jun 1;55(22):2427-34. doi: 10.1016/j.jacc.2010.02.031.
PubMed 20510210Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Buttner HJ, Neumann FJ. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents. J Am Coll Cardiol. 2008 May 20;51(20):1925-34. doi: 10.1016/j.jacc.2007.12.056.
PubMed 18482659
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Degree of Peri-Interventional Platelet Inhibition After Loading With Clopidogrel on Early Clinical Outcome of Elective Coronary Stent Placement
- ClinicalTrials.gov ID
- NCT00457236
- Acronym / sponsor ID
- EXCELSIOR / HZ-BK-2003-1
- Conditions
- Coronary Artery Disease, Drug Resistance
- Keywords
- Clopidogrel, Coronary Artery Disease, Dose-Response Relationship, Drug, Drug Resistance, PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants
- Lead sponsor
- University Heart Center Freiburg - Bad KrozingenUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Dec 2007 (estimated)
- First posted
- 6 Apr 2007 (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 impact of the variability in platelet response after loading with clopidogrel on the peri-interventional risk of patients undergoing PCI.
Detailed description
Background: Platelet responses after loading with clopidogrel are highly variable. The impact of this variability on the peri-interventional risk of patients undergoing PCI has not been investigated prospectively.
Objectives: Our prospective study test the hypothesis that the 30-day clinical outcome of elective percutaneous catheter intervention (PCI) differs between strata defined by quartiles of platelet aggregation after loading with 600mg of clopidogrel. Further on we will investigate impact of the variability in platelet response on long-term outcome after PCI.
Methods: Our study will include consecutive patients undergoing elective coronary stent placement. Before PCI, patients receive a loading dose of 600mg of clopidogrel followed by 75mg daily. Primary end point is the 30-day composite of death, myocardial infarction and target lesion revascularization (MACE). Platelet aggregation was assessed immediately before PCI by optical aggregometry (5µmol/L ADP).
Sample size calculation was based on ISAR-REACT which comprised a cohort with similar selection criteria and treatment strategy. Thus, we assume an incidence of the primary end point of 4.2%. We design our study to test the hypothesis that the incidence of the primary end point differed by quartiles of ADP-induced platelet aggregation. We intend to have a power of 0.80 to detect an effect size of 0.015 (for example 3-fold risk in 4th quartile) with a 2-sided P-value less than 0.05. With these assumptions we obtain a sample size of at least 748 and aime for a cohort of 800.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
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 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.
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 6 Apr 2007.
- Results publication: PubMed 17084243Hochholzer W, Trenk D, Bestehorn HP, Fischer B, Valina CM, Ferenc M, Gick M, Caputo A, Buttner HJ, Neumann FJ. Impact of the degree of peri-interventional platelet inhibition after loading with clopidogrel on early clinical outcome of elective coronary stent placement. J Am Coll Cardiol. 2006 Nov 7;48(9):1742-50. doi: 10.1016/j.jacc.2006.06.065. Epub 2006 Oct 17.
- Derived from this study: PubMed 41525016Kille A, Kaier K, Nuhrenberg T, Franke K, Valina CM, Yang X, Leibundgut G, Neumann FJ, Westermann D, Hochholzer W, Tsimikas S. Oxidized phospholipids on plasminogen are associated with reduced platelet surface marker expression and intrinsic reactivity. J Thromb Thrombolysis. 2026 Feb;59(2):261-271. doi: 10.1007/s11239-025-03210-2. Epub 2026 Jan 12.
- Derived from this study: PubMed 40808656Tsimikas S, Kille A, Kaier K, Nuhrenberg T, Franke K, Valina CM, Yang X, Leibundgut G, Neumann FJ, Westermann D, Hochholzer W. Oxidized Phospholipids on ApoB-100, Platelet Activation and Reactivity, and Long-Term Cardiovascular Outcomes. Arterioscler Thromb Vasc Biol. 2025 Oct;45(10):1935-1944. doi: 10.1161/ATVBAHA.125.322347. Epub 2025 Aug 14.
- Derived from this study: PubMed 29349545Valina CM, Merz S, Loffelhardt N, Amann M, Ferenc M, Stratz C, Neumann FJ, Hochholzer W. Risk of discontinuation of clopidogrel after 1 month following bare-metal stents: a propensity-score adjusted comparison with continued administration of clopidogrel after drug-eluting stents. J Thromb Thrombolysis. 2018 Apr;45(3):432-439. doi: 10.1007/s11239-018-1613-6.
- Derived from this study: PubMed 25127973Hochholzer W, Valina CM, Stratz C, Amann M, Schlittenhardt D, Buttner HJ, Trenk D, Neumann FJ. High-sensitivity cardiac troponin for risk prediction in patients with and without coronary heart disease. Int J Cardiol. 2014 Sep 20;176(2):444-9. doi: 10.1016/j.ijcard.2014.07.094. Epub 2014 Aug 4.
- Derived from this study: PubMed 21685174Trenk D, Hochholzer W, Fromm MF, Zolk O, Valina CM, Stratz C, Neumann FJ. Paraoxonase-1 Q192R polymorphism and antiplatelet effects of clopidogrel in patients undergoing elective coronary stent placement. Circ Cardiovasc Genet. 2011 Aug 1;4(4):429-36. doi: 10.1161/CIRCGENETICS.111.960112. Epub 2011 Jun 17.
- Derived from this study: PubMed 20510210Hochholzer W, Trenk D, Fromm MF, Valina CM, Stratz C, Bestehorn HP, Buttner HJ, Neumann FJ. Impact of cytochrome P450 2C19 loss-of-function polymorphism and of major demographic characteristics on residual platelet function after loading and maintenance treatment with clopidogrel in patients undergoing elective coronary stent placement. J Am Coll Cardiol. 2010 Jun 1;55(22):2427-34. doi: 10.1016/j.jacc.2010.02.031.
- Derived from this study: PubMed 18482659Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Buttner HJ, Neumann FJ. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents. J Am Coll Cardiol. 2008 May 20;51(20):1925-34. doi: 10.1016/j.jacc.2007.12.056.
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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?
An observational study of 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: status not confirmed, as of the sponsor's last update on 6 Apr 2007. 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?
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?
On the ClinicalTrials.gov record for NCT00457236, which also lists 8 linked publications.
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 6 Apr 2007.