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

NCT02096419 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2014-08-15

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Clopidogrel dose adjustment

Patients in the interventional arm will receive clopidogrel dose adjustment to maintain optimal platelet reactivity determined by Multiplate function analyzer (19-46U). They will undergo platelet function testing on day 1,2,3,7,30 and month 2,3,6,9 and 12. On first two measurements patients will receive up to 2 additional clopidogrel loading doses (600 mg) and put on 150 mg and 75 mg a day if platelet reactivity \>18U and \<18U, respectively. Maintenance dose will be determined on following measurements - increased by 75 mg if \>46U; not changed if 19-46U; decreased by 75 mg if \<19U. Minimal dose - 75 mg; maximal dose 300 mg (for patients \>70 years 150 mg)

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    collaborator OTHER

  • Ministry of Science, Education and Sport, Republic of Croatia

    collaborator OTHER_GOV

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Davor Milicic, MD, PhD · University of Zagreb School of Medicine

  • Jure Samardzic, MD · University of Zagreb School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096419 on ClinicalTrials.gov