NCT00302913

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2005

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 4, 2006

Status Verified

February 1, 2006

First QC Date

March 14, 2006

Last Update Submit

June 29, 2006

Conditions

Coronary Artery DiseaseDrug Resistance

Keywords

ClopidogrelCoronary Artery DiseaseDose-Response Relationship, DrugDrug ResistancePCI

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Adjustment of clopidogrel doseDRUG

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 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

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

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
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

December 1, 2005

Study Completion

June 1, 2006

Last Updated

July 4, 2006

Record last verified: 2006-02

Locations

DE(1)