Resistance on Antithrombotic Drugs in Ischemic Heart Disease

NCT ID: NCT00742430

Last Updated: 2012-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Resistant

patients who are resistant to standard antithrombotic drugs

PCI

Intervention Type PROCEDURE

percutaneous coronary intervention in stable coronary artery disease

Nonresistant

patients who are not resistant to standard dual antithrombotic drugs

PCI

Intervention Type PROCEDURE

percutaneous coronary intervention in stable coronary artery disease

Interventions

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PCI

percutaneous coronary intervention in stable coronary artery disease

Intervention Type PROCEDURE

Other Intervention Names

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stenting PTCA balloon dilatation

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Davor Milicic

prof. dr. sc. F.E.S.C.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davor Milicic, prof.dr.sc.

Role: PRINCIPAL_INVESTIGATOR

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

Bosko Skoric, dr.

Role: STUDY_CHAIR

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

Locations

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Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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108-1081875-1993

Identifier Type: -

Identifier Source: org_study_id

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