Resistance on Antithrombotic Drugs in Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT00742430

Recruitment Status : Completed

First Posted : August 27, 2008

Last Update Posted : February 14, 2012

Sponsor:

Information provided by (Responsible Party):

Davor Milicic, University of Zagreb

Study Description

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).

Condition or disease	Intervention/treatment
Coronary Artery Disease	Procedure: PCI

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 Design

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Study Type :	Observational
Actual Enrollment :	141 participants
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
Study Start Date :	February 2009
Actual Study Completion Date :	August 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Clopidogrel resistance

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Groups and Cohorts

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: 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

Outcome Measures

Primary Outcome Measures :

Major adverse coronary event [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742430

Locations

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

Sponsors and Collaborators

University of Zagreb

Investigators

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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

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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
First Posted:	August 27, 2008 Key Record Dates
Last Update Posted:	February 14, 2012
Last Verified:	February 2012

Keywords provided by Davor Milicic, 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:

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Myocardial Ischemia Aspirin Clopidogrel Coronary Artery Disease Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents

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