NCT00742430

Brief Summary

The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

First QC Date

August 26, 2008

Last Update Submit

February 11, 2012

Conditions

Coronary Artery Disease

Keywords

aspirin resistancecoronary artery diseaseclopidogrel resistancemajor adverse cardiac eventsmultiplate platelet function analyserpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Major adverse coronary event

    12 months

Study Arms (2)

Resistant

patients who are resistant to standard antithrombotic drugs

Procedure: PCI

Nonresistant

patients who are not resistant to standard dual antithrombotic drugs

Procedure: PCI

Interventions

PCIPROCEDURE

percutaneous coronary intervention in stable coronary artery disease

Also known as: stenting, PTCA, balloon dilatation
NonresistantResistant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with coronary artery disease

You may qualify if:

  • Elective PCI
  • \> 7 days on aspirin 100mg therapy before the intervention
  • \> 7 days on clopidogrel 75mg therapy before the intervention

You may not qualify if:

  • Loading dose of clopidogrel
  • \< 7 days on aspirin therapy before the intervention
  • Myocardial infarction less than 30 days before the intervention
  • Cerebrovascular incident less that three months before the intervention
  • Haemorrhagic diathesis
  • Trc \< 100
  • Htc \< 30%
  • Creatinine \> 140

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular Diseases

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Davor Milicic, prof.dr.sc.

    Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia

    PRINCIPAL INVESTIGATOR

  • Bosko Skoric, dr.

    Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr. sc. F.E.S.C.

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 27, 2008

Study Start

February 1, 2009

Study Completion

August 1, 2011

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

CR(1)