Resistance on Antithrombotic Drugs in Ischemic Heart Disease - Full Text View

Purpose

The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good corelation with incidence of major adverse cardiac events in patients with CAD.

Condition

Coronary Artery Disease

MedlinePlus related topics:

Coronary Artery Disease Heart Diseases

Drug Information available for:

Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	180
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011

Detailed Description:

Our plan is to enroll 180 patients with diagnosed CAD who electively undergo PCI. Blood samples will be taken before and after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance using Multiplate platelet function analyzer we will try to find resistance corelation 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 PTCA
> 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

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

Contacts


Contact: Davor Milicic, prof.dr.sc.	+38512367467

Contact: Jure Samardzic, dr.	+38512367467	jure.samardzic@gmail.com

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

Responsible Party:	University od Zagreb ( Davor Milicic, prof.dr.sc. F.E.S.C. )
Study ID Numbers:	108-1081875-1993
First Received:	August 26, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00742430
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

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Heart Diseases

Aspirin

Clopidogrel

Myocardial Ischemia

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	University of Zagreb
Information provided by:	University of Zagreb
ClinicalTrials.gov Identifier:	NCT00742430