DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Continuous Clopidogrel Dose Adjustment in Acute Coronary Syndrome Patients With High On-treatment Platelet Reactivity

Information source: University of Zagreb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Clopidogrel dose adjustment (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Zagreb

Official(s) and/or principal investigator(s):
Davor Milicic, MD, PhD, Study Chair, Affiliation: University of Zagreb School of Medicine
Jure Samardzic, MD, Principal Investigator, Affiliation: University of Zagreb School of Medicine

Summary

The purpose of this study is to determine whether continuous clopidogrel dose adjustment targeted after platelet function testing improves outcomes during 12 months of follow-up in acute coronary syndrome patients treated with coronary artery stenting and with determined high platelet reactivity on clopidogrel.

Clinical Details

Official title: Effect of Continuous Clopidogrel Dosing Targeted After Platelet Function Testing in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention With High On-treatment Platelet Reactivity

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: clinical outcome - composite endpoint of total cardiovascular death, non-fatal myocardial infarction, target vessel revascularization and ischemic stroke

Secondary outcome: number of bleeding events

Detailed description: Dual antiplatelet therapy (DAPT) with aspirin and P2Y12 receptor antagonists during 12 months presents cornerstone treatment in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Clopidogrel is the most widely used P2Y12 inhibitor despite it's limitations that include highly variable P2Y12-receptor inhibition which causes wide interindividual platelet reactivity variability. Since high on-treatment platelet reactivity (HTPR) on clopidogrel is strongly associated with adverse events, antiplatelet therapy tailoring has been vastly investigated to determine whether individualized approach could improve outcomes. In the time of progressive personalized approach to therapy, effective strategies are needed to minimize the risk of ischemic adverse events without increasing the risk for bleeding. Aim of this study is to investigate whether continuous clopidogrel dose adjustment according to platelet function testing (PFT) using Multiplate® function analyzer (Roche Diagnostics, Mannheim, Germany) could decrease the rate of adverse events in ACS patients treated with PCI and with HTPR during early and late period of DAPT treatment. Cut off values for HTPR and enhanced platelet response were set according to the consensus statement at >46 U and <19 U, respectively. PFT and therapy tailoring was performed at day 1, 2, 3, 7, 30 and month 2, 3, 6, 9 and 12.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- acute coronary syndrome patients treated with successful PCI

- age 18-80 years

- determined high on-treatment platelet reactivity

Exclusion Criteria:

- continuous postinterventional glycoprotein (GP) IIbIIIa receptor inhibitor infusion

- thrombocytopenia (<150x109/L)

- significant renal insufficiency (creatinine>200 ┬Ámol/L)

- anemia (Htc<30%)

- hemorrhagic diathesis

- history of intracranial bleeding or ischemic cerebrovascular insult 6 months before

- major operation 6 weeks before

- concomitant chronic anticoagulation therapy

- age <18 years and >80 years

Locations and Contacts

University Hospital Centre Zagreb, Zagreb 10000, Croatia
Additional Information

Starting date: February 2012
Last updated: August 14, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017