Resistance on Antithrombotic Drugs in Ischemic Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Davor Milicic, University of Zagreb
ClinicalTrials.gov Identifier:
NCT00742430
First received: August 26, 2008
Last updated: February 11, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention
Coronary Artery Disease
Procedure: PCI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Aspirin and Clopidogrel Resistance in Ischemic Heart Disease Using Multiplate Function Analyser and it's Correlation With Major Adverse Cardiac Events

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • Major adverse coronary event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: February 2009
Study Completion Date: August 2011
Groups/Cohorts Assigned Interventions
Resistant
patients who are resistant to standard antithrombotic drugs
Procedure: PCI
percutaneous coronary intervention in stable coronary artery disease
Other Names:
  • stenting
  • PTCA
  • 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:
  • stenting
  • PTCA
  • balloon dilatation

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with coronary artery disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742430

Locations
Croatia
Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro
Zagreb, Croatia, 10000
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Davor Milicic, prof. dr. sc. F.E.S.C., University of Zagreb
ClinicalTrials.gov Identifier: NCT00742430     History of Changes
Other Study ID Numbers: 108-1081875-1993
Study First Received: August 26, 2008
Last Updated: February 11, 2012
Health Authority: Croatia: Ministry of Science, Education and Sports

Keywords provided by University of Zagreb:
aspirin resistance
coronary artery disease
clopidogrel resistance
major adverse cardiac events
multiplate platelet function analyser
percutaneous coronary intervention

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014