Resistance on Antithrombotic Drugs in Ischemic Heart Disease

February 11, 2012 updated by: Davor Milicic, University of Zagreb

Assessment of Aspirin and Clopidogrel Resistance in Ischemic Heart Disease Using Multiplate Function Analyser and it's Correlation With Major Adverse Cardiac Events

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our plan is to enroll 180 patients with diagnosed CAD who electively undergo percutaneous coronary intervention (PCI). Blood samples will be taken just before the procedure and one day after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance incidence using Multiplate platelet function analyzer we will also try to find resistance correlation with the incidence of major adverse cardiac events in a one year follow up.

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with coronary artery disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Resistant
patients who are resistant to standard antithrombotic drugs
Procedure: PCI
percutaneous coronary intervention in stable coronary artery disease
Other Names:
  • PTCA
  • stenting
  • balloon dilatation
Nonresistant
patients who are not resistant to standard dual antithrombotic drugs
Procedure: PCI
percutaneous coronary intervention in stable coronary artery disease
Other Names:
  • PTCA
  • stenting
  • balloon dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse coronary event
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Investigators

  • Principal Investigator: Davor Milicic, prof.dr.sc., Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia
  • Study Chair: Bosko Skoric, dr., Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 11, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108-1081875-1993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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