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

NCT02096419 | Completed Phase 4

• 1 other identifier: 108-1081875-1993-1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

clopidogrel; platelet reactivity; acute coronary syndrome; tailoring therapy; outcome

Outcome Measures

Primary Outcomes (1)

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

  Data will be collected during the entire follow up period on interviews and analyzing patient medical data.

  12 months

Secondary Outcomes (1)

• number of bleeding events

  12 months

Study Arms (2)

control group

NO INTERVENTION

Patients in this group will receive standard clopidogrel dose

interventional group

EXPERIMENTAL

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)

Drug: Clopidogrel dose adjustment

Interventions

Clopidogrel dose adjustment DRUG

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)

Also known as: antiplatelet therapy tailoring

interventional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute coronary syndrome patients treated with successful PCI
• age 18-80 years
• determined high on-treatment platelet reactivity

You may not qualify if:

• continuous postinterventional glycoprotein (GP) IIbIIIa receptor inhibitor infusion
• thrombocytopenia (\<150x109/L)
• significant renal insufficiency (creatinine\>200 µmol/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

Sponsors & Collaborators

• University of Zagreb: lead
• Clinical Hospital Centre Zagreb: collaborator
• Ministry of Science, Education and Sport, Republic of Croatia: collaborator

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Davor Milicic, MD, PhD

  University of Zagreb School of Medicine

  STUDY CHAIR

• Jure Samardzic, MD

  University of Zagreb School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jure Samardzic M.D.

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 26, 2014
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

CR (1)