NCT00457236

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 6, 2007

Status Verified

April 1, 2007

First QC Date

April 4, 2007

Last Update Submit

April 5, 2007

Conditions

Coronary Artery DiseaseDrug Resistance

Keywords

ClopidogrelCoronary Artery DiseaseDose-Response Relationship, DrugDrug ResistancePCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Related Publications (7)

  • 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.

    PMID: 17084243RESULT

  • Tsimikas 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.

    PMID: 40808656DERIVED

  • Valina 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.

    PMID: 29349545DERIVED

  • Hochholzer 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.

    PMID: 25127973DERIVED

  • Trenk 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.

    PMID: 21685174DERIVED

  • Hochholzer 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.

    PMID: 20510210DERIVED

  • Trenk 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.

    PMID: 18482659DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Franz-Josef Neumann, MD

    Heart Center Bad Krozingen, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

March 1, 2003

Study Completion

December 1, 2007

Last Updated

April 6, 2007

Record last verified: 2007-04

Locations

DE(1)