Resistance on Antithrombotic Drugs in Ischemic Heart Disease

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742430
• Other study ID #: 108-1081875-1993
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: February 11, 2012
• Start date: February 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Science, Education and Sports
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• PCI
percutaneous coronary intervention in stable coronary artery disease

Locations

Country	Name	City	State
Croatia	Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse coronary event		12 months	Yes