ClinicalTrials.Veeva

Menu

Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27 (PLATO-dose)

L

Les Laboratoires des Médicaments Stériles

Status and phase

Completed
Phase 4

Conditions

Overweight
Cardiovascular Disease

Treatments

Drug: clopidogrel

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01509365
03 PID 11

Details and patient eligibility

About

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.

Full description

The goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with BMI ≥ 27 kg.m-2 1 - Biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation.

2 - Clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.

Enrollment

116 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female,
  • Old (e) of more than 20 years
  • BMI ≥ 27kg.m-2
  • Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage)
  • Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days)

Exclusion criteria

  • Patients unwilling.
  • Patient participating in another study.
  • Patients with cardiogenic shock
  • Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
  • Patients scheduled for surgery in less than 6 months
  • ischemic stroke older than 6 weeks.
  • History of hemorrhagic stroke (any time)
  • Patients on or candidates for AVK
  • Patients with a different anti ADP (ticlopidine, prasugrel)
  • Patients with an indication against clopidogrel (side effects, bleeding ...)
  • Thrombocytopenia < 100000/mm3
  • anemia (Ht < 30%)
  • Thrombocythaemia (Ht > 52%)
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

116 participants in 3 patient groups

sensible
No Intervention group
Description:
Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.
simple dose
Active Comparator group
Description:
Patients who show suboptimal response to loading dose of clopidogrel and receive 1x75 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year.
Treatment:
Drug: clopidogrel
double dose
Experimental group
Description:
Patients who show suboptimal response to loading dose of clopidogrel and receive 1x150 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year.
Treatment:
Drug: clopidogrel

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems