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

Primary Purpose

Cardiovascular Disease, Overweight

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
clopidogrel
clopidogrel
Sponsored by
Les Laboratoires des Médicaments Stériles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring cardiovascular disease, maintenance dose, clopidogrel, overweight, antiplatelet agents

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • cardiology department, hospital Fattouma Bourguiba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

sensible

simple dose

double dose

Arm Description

Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.

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.

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.

Outcomes

Primary Outcome Measures

Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation

Secondary Outcome Measures

ADP-induced platelet aggregation assessed by VerifyNow test

Full Information

First Posted
January 9, 2012
Last Updated
May 6, 2015
Sponsor
Les Laboratoires des Médicaments Stériles
Collaborators
University Hospital Fattouma Bourguiba
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1. Study Identification

Unique Protocol Identification Number
NCT01509365
Brief Title
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27
Acronym
PLATO-dose
Official Title
Evaluation the Effect of the Double Maintenance Dose of Clopidogrel Versus Single Dose in Patients With Coronary Artery Disease With a BMI ≥ 27 kg.m-2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles
Collaborators
University Hospital Fattouma Bourguiba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Overweight
Keywords
cardiovascular disease, maintenance dose, clopidogrel, overweight, antiplatelet agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sensible
Arm Type
No Intervention
Arm Description
Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.
Arm Title
simple dose
Arm Type
Active Comparator
Arm 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.
Arm Title
double dose
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
Primary Outcome Measure Information:
Title
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ADP-induced platelet aggregation assessed by VerifyNow test
Time Frame
7 days after selection of patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faouzi Maatouk, MD
Organizational Affiliation
hospital Fattouma Bourguiba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khaldoun Ben Hamda, MD
Organizational Affiliation
Hospital Fattouma Bourguiba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sonia Hamdi, MD
Organizational Affiliation
Hospital Fattouma Bourguiba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohsen Hassine
Organizational Affiliation
Hospital Fattouma Bourguiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
cardiology department, hospital Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

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Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27

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